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An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect (ADIPOSTRESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Maastricht University Medical Center
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01559415
First received: March 12, 2012
Last updated: November 25, 2014
Last verified: November 2014
  Purpose

Almost half of the Dutch population is currently characterized by overweight and obesity. Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight regain after weight loss: the yoyo-effect. The primary objective of this study is to investigate the association between the weight-loss-induced cellular stress response and the rate of weight regain. The secondary objective is to investigate the differences in cellular stress response and weight regain after rapid and slow weight loss. To investigate this, subjects will receive meal replacements replacing either all or part of the daily meals during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up period subjects will receive dietary advice according to the Dutch recommendations for healthy eating. The association between the amount of weight regain after the weight loss period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein expression and gene polymorphisms in selected genes.


Condition Intervention
Obesity
Weight Loss
Diet
Other: Meal replacement diet using Modifast
Other: Normal diet combined with Modifast diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • change in weight following weight loss [ Time Frame: at 9 weeks and at 46 weeks ] [ Designated as safety issue: No ]
    VLCD diet group

  • change in weight following weight loss [ Time Frame: at 16 weeks and at 53 weeks ] [ Designated as safety issue: No ]
    LCD diet group


Secondary Outcome Measures:
  • change in adipokine profile due to dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]

    In VLCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa


  • change in adipokine during weight stable-period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and after 9 weeks ] [ Designated as safety issue: No ]

    In VLCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa


  • change in adipokine profile during follow-up (VLCD-group) [ Time Frame: at 9 weeks and after follow-up at 46 weeks ] [ Designated as safety issue: No ]

    In VLCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa


  • change in adipokine profile due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]

    In LCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa


  • change in adipokine profile during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]

    In LCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa


  • change in adipokine profile during follow-up (LCD-group) [ Time Frame: at 16 weeks and after follow-up at 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa


  • Changes in adipokine profile in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa


  • change in adipokine profile in relation to weight regain during follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group and VLCD-group

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa


  • change in parameters of adipocyte fat metabolism due to dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]

    In VLCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  • change in parameters of adipocyte fat metabolism during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]

    In VLCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  • change in parameters of adipocyte fat metabolism during follow-up period (VLCD-group) [ Time Frame: at 9 weeks and after follow-up at 46 weeks ] [ Designated as safety issue: No ]

    In VLCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  • change in parameters of adipocyte fat metabolism due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]

    In LCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  • change in parameters of adipocyte fat metabolism during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]

    In LCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  • change in parameters of adipocyte fat metabolism during follow-up (LCD-group) [ Time Frame: at 16 weeks and after follow-up at 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  • Changes in parameters of adipocyte fat metabolism in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  • change in parameters of adipocyte fat metabolism in relation to weight regain during follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group and VLCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  • change in in-vivo adipose tissue metabolism due to dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]

    In VLCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  • change in in-vivo adipose tissue metabolism during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]

    In VLCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  • change in in-vivo adipose tissue metabolism during follow-up period (VLCD-group) [ Time Frame: at 9 weeks and after follow-up period at 46 weeks ] [ Designated as safety issue: No ]

    In VLCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  • change in in-vivo adipose tissue metabolism due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]

    In LCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  • change in in-vivo adipose tissue metabolism during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]

    In LCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  • change in in-vivo adipose tissue metabolism during follow-up period (LCD-group) [ Time Frame: at 16 weeks and after follow-up period at 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  • change in in-vivo adipose tissue metabolism in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  • change in in-vivo adipose tissue metabolism in relation to weight regain during follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group and VLCD-group

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  • change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]

    VLCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  • change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]

    VLCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  • change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (VLCD-group) [ Time Frame: at 9 weeks and after follow-up period at 46 weeks ] [ Designated as safety issue: No ]

    VLCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  • change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]

    LCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  • change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]

    LCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  • change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (LCD-group) [ Time Frame: at 16 weeks and after follow-up period ] [ Designated as safety issue: No ]

    LCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  • change in the adipocyte extracellular matrix gene and protein expression profile in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  • change in the adipocyte extracellular matrix gene and protein expression profile in relation to weight regain during follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group and VLCD-group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  • change in adipocyte stress proteins expression due to dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]

    VLCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  • change in adipocyte stress proteins expression during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]

    VLCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  • change in adipocyte stress proteins expression during follow-up period (VLCD-group) [ Time Frame: at 9 weeks and after follow-up period at week 46 ] [ Designated as safety issue: No ]

    VLCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  • change in adipocyte stress proteins expression due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]

    LCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  • change in adipocyte stress proteins expression during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at week 16 ] [ Designated as safety issue: No ]

    LCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  • change in adipocyte stress proteins expression during follow-up period (LCD-group) [ Time Frame: at week 16 and after follow-up period at 53 weeks ] [ Designated as safety issue: No ]

    LCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  • change in adipocyte stress proteins expression in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  • change in adipocyte stress proteins expression in relation to weight regain during follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group and VLCD-group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  • change in physiological parameters due to dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat


  • change in physiological parameters during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat


  • change in physiological parameters during follow-up period (VLCD-group) [ Time Frame: at 9 weeks and after follow-up at 46 weeks ] [ Designated as safety issue: No ]

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat


  • change in physiological parameters due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat


  • change in physiological parameters during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat


  • change in physiological parameters during follow-up (LCD-group) [ Time Frame: at 16 weeks and after follow-up at 53 weeks ] [ Designated as safety issue: No ]

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat


  • Changes in physiological parameters in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat


  • Changes in physiological parameters in relation to weight regain during follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat


  • change in plasma metabolic parameters due to dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides


  • change in plasma metabolic parameters during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides


  • change in plasma metabolic parameters during follow-up period (VLCD-group) [ Time Frame: at 9 weeks and after follow-up at 46 weeks ] [ Designated as safety issue: No ]

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides


  • change in plasma metabolic parameters due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides


  • change in plasma metabolic parameters during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides


  • change in plasma metabolic parameters during follow-up (LCD-group) [ Time Frame: at 16 weeks and after follow-up at 53 weeks ] [ Designated as safety issue: No ]

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides


  • Changes in plasma metabolic parameters in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides


  • Changes in plasma metabolic parameters in relation to weight regain during follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group and VLCD-group

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides


  • change in fat cell size and fat cell number due to the dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]
  • change in fat cell size and fat cell number during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]
  • change in fat cell size and fat cell number during follow-up period (VLCD-group) [ Time Frame: at 9 weeks and after follow-up at 46 weeks ] [ Designated as safety issue: No ]
  • change in fat cell size and fat cell number due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]
  • change in fat cell size and fat cell number during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]
  • change in fat cell size and fat cell number during follow-up (LCD-group) [ Time Frame: at 16 weeks and after follow-up at 53 weeks ] [ Designated as safety issue: No ]
  • Changes in fat cell size and fat cell number in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]
  • Changes in fat cell size and fat cell number in relation to weight regain after weight loss [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]
    In LCD-group and VLCD-group

  • change in breath volatile organic compounds due to the dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]
  • change in breath volatile organic compounds during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]
  • change in breath volatile organic compounds during follow-up period (VLCD-group) [ Time Frame: at 9 weeks and after follow-up at 46 weeks ] [ Designated as safety issue: No ]
  • change in breath volatile organic compounds due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]
  • change in breath volatile organic compounds during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]
  • change in breath volatile organic compounds during follow-up (LCD-group) [ Time Frame: at 16 weeks and after follow-up at 53 weeks ] [ Designated as safety issue: No ]
  • Changes in breath volatile organic compounds in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]
  • Changes in breath volatile organic compounds in relation to weight regain during follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]
    In LCD-group and VLCD-group

  • change in inflammatory parameters due to the dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]

    In VLCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  • change in inflammatory parameters during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]

    In VLCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  • change in inflammatory parameters during follow-up period (VLCD-group) [ Time Frame: at 9 weeks and after follow-up at 46 weeks ] [ Designated as safety issue: No ]

    In VLCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  • change in inflammatory parameters due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]

    In LCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  • change in inflammatory parameters during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]

    In LCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  • change in inflammatory parameters during follow-up (LCD-group) [ Time Frame: at 16 weeks and after follow-up at 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  • Changes in inflammatory parameters in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  • Changes in inflammatory parameters in relation to weight regain during the follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  • Changes in protein concentration of metabolic parameters due to the dietary intervention (VLCD-group) [ Time Frame: at baseline and after 5 weeks of VLCD diet ] [ Designated as safety issue: No ]

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS


  • Changes in protein concentration of metabolic parameters during weight-stable period (VLCD-group) [ Time Frame: after 5 weeks of VLCD diet and at 9 weeks ] [ Designated as safety issue: No ]

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS


  • change in protein concentration of metabolic parameters during follow-up (VLCD-group) [ Time Frame: at 9 weeks and after follow-up at 46 weeks ] [ Designated as safety issue: No ]

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS


  • change in protein concentration of metabolic parameters due to dietary intervention (LCD-group) [ Time Frame: at baseline and after 12 weeks of LCD diet ] [ Designated as safety issue: No ]

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS


  • change in protein concentration of metabolic parameters during weight-stable period (LCD-group) [ Time Frame: after 12 weeks of LCD diet and at 16 weeks ] [ Designated as safety issue: No ]

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS


  • change in protein concentration of metabolic parameters during follow-up (LCD-group) [ Time Frame: at 16 weeks and after follow-up at 53 weeks ] [ Designated as safety issue: No ]

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS


  • change in protein concentration of metabolic parameters in the LCD-group compared to the VLCD-group [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS


  • change in protein concentration of metabolic parameters in relation to weight regain during follow-up [ Time Frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks ] [ Designated as safety issue: No ]

    In LCD-group and VLCD-group

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS



Estimated Enrollment: 58
Study Start Date: March 2012
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Very Low Calorie Diet Other: Meal replacement diet using Modifast
modifast intensive diet replacing all regular meals (500 kcal/d) for 5 weeks
Active Comparator: Low Calorie Diet
1250 kcal diet in which Modifast is given in combination with a normal diet
Other: Normal diet combined with Modifast diet
Combination of modifast and regular diet (1250 kcal/d) for 3 months

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age (years): 20-65
  • Body Mass Index (kg/m2): 28-35
  • Non-smokers

Exclusion Criteria:

  • Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1)
  • marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female)
  • planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator;
  • blood donation within the past 2 months prior to the study
  • weight change of >3 kg within 2 months prior to the study
  • psychiatric disease (based on medical history only)
  • pregnant or lactating women, or women planning to become pregnant within the next 12 months
  • surgically treated obesity
  • participation in other clinical studies within the last 3 months
  • drug abuse (based on clinical judgment)
  • unable to give informed consent
  • unable to engage in a low-calorie diet
  • unable to lose more then 8% of body weight after weight-loss period
  • following a special diet (vegetarian, Atkins or other).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559415

Contacts
Contact: Roel Vink, MSc +31433882112 r.vink@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Roel Vink, MSc    0031-0433882112    r.vink@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Marleen van Baak, Professor Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01559415     History of Changes
Other Study ID Numbers: 38099
Study First Received: March 12, 2012
Last Updated: November 25, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Adipocytes

Additional relevant MeSH terms:
Body Weight
Weight Loss
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014