Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Low Glycemic Index Diet as Prevention of the Catch-up Fat Phenomenon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Manfred James Müller, University of Kiel
ClinicalTrials.gov Identifier:
NCT01737034
First received: November 26, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

The catch-up fat phenomenon is an evolutionary conserved physiological response to a starvationrefeeding cycle. It is characterized by long-term suppression of thermogenesis, reduced body protein regain and an increase in fat mass above basal level during refeeding. Clinically, it characterises weight cycling in overweight patients which is associated with increasing fat mass (visceral fat) and increased morbidity (e.g. insulin resistance, inflammation). In this project, the physiological, cellular and molecular mechanisms of this phenomenon will be investigated in humans, mice and C. elegans. It is hypothesized that refeeding a low GI (=glycemic index)- diet after weight loss prevents the catchup fat phenomenon and its sequelae. This translational research will provide comprehensive insights into the catch-up fat phenomenon as well as provide a suitable strategy of its prevention.


Condition Intervention
Dietary Intervention
Other: dietary intervention by varying GI diets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Ätiologie, Pathophysiologie Und Prävention Einer überschießenden Körperfettzunahme Nach Gewichtsreduktion - Vermeidung Des JoJo-Effektes in Der Behandlung Von Übergewicht

Further study details as provided by University of Kiel:

Primary Outcome Measures:
  • Changes in body composition and energy metabolism after 3 weeks of underfeeding and 2 following weeks of refeeding [ Time Frame: Body composition measurement after 4 and 6 study weeks ] [ Designated as safety issue: No ]
    Body composition measurement including BODPOD, QMR, BIA Energy Metabolism measurement using indirect calorimetry


Enrollment: 32
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low GI, low GI
low GI diet (semi starvation phase) followed by low GI diet in the refeeding phase
Other: dietary intervention by varying GI diets
The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.
Experimental: low GI, high GI
low GI diet (semi starvation phase) followed by high GI diet in the refeeding phase
Other: dietary intervention by varying GI diets
The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.
Experimental: high GI, low GI
high GI diet (semi starvation phase) followed by low GI diet in the refeeding phase
Other: dietary intervention by varying GI diets
The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.
Experimental: high GI, high GI
high GI diet (semi starvation phase) followed by high GI diet in the refeeding phase
Other: dietary intervention by varying GI diets
The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.

Detailed Description:

In a human intervention study, changes in physiological, metabolic, and neuroendocrine functions in response to weight cycling will be investigated under controlled conditions in normal weight subjects. The mechanisms of the catch-up fat phenomenon are analysed starting from stable energy balance followed by overfeeding, weight loss and weight regain following weight loss (refeeding). Changes in body composition (including ectopic fat), metabolism (resting energy expenditure, substrate oxidation rates, insulin resistance) and plasma hormone concentrations will be assessed. Fat tissue probes will be used to characterise key enzymes and signalling pathways, redox status and whole genome expression. Modulation of the hormonal response to weight cycling is brought about by varying macronutrient content and glycemic index of the diets. We hypothesize that, insulin and leptin resistance are explained by increased insulin secretion during the refeeding period. Both, adaptive thermogenesis as well as insulin and leptin resistance can be ameliorated by attenuation of the increase in insulin and leptin secretion during refeeding a low GI diet after weight loss.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal weight (BMI 20-24 kg/m2), normal fat mass

Exclusion Criteria:

  • smoking, chronic diseases, drug intake, nutrient allergies, lactose intolerance, pacemaker, metalliferous implants
  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: NCT01737034

Locations
Germany
Institute of Human Nutrition
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Kiel
Investigators
Study Chair: Manfred J. Müller, Prof. Institute of Human Nutrition, University of Kiel
  More Information

Additional Information:
No publications provided by University of Kiel

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Manfred James Müller, Principal Investigator, University of Kiel
ClinicalTrials.gov Identifier: NCT01737034     History of Changes
Other Study ID Numbers: BMBF 0315681
Study First Received: November 26, 2012
Last Updated: November 29, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Kiel:
partitioning of weight gain
refeeding
catch-up fat phenomenon
glycemic index

ClinicalTrials.gov processed this record on November 20, 2014