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Dietary Lipids, Energy Expenditure and Obesity Biomarkers

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ClinicalTrials.gov Identifier: NCT02656940
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Vanessa Chaia Kaippert, Universidade Federal do Rio de Janeiro

Brief Summary:
The purpose of this study is to determine whether the modulation of dietary lipids are effective in the treatment of obesity and comorbidities.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Group 1 - diet rich in n-3 and n-6 PUFA Dietary Supplement: Group 2 - diet rich in MUFA Dietary Supplement: Group 3 - Placebo group Not Applicable

Detailed Description:
Obesity is a complex disease of multifactorial etiology and difficult to control. Among lifestyle changes proposed to the treatment of this disease and comorbidities, there is the modulation of dietary lipid composition. This study aimed to evaluate the effects of the modulation of fatty acid (FA) polyunsaturated (PUFA) and monounsaturated (MUFA) in energy expenditure (EE), weight loss, body composition, lipid and glycemic profile, free fatty acids (FFA), glycerol, adiponectin, leptin, blood pressure (BP), feeding behavior and expression of PPARα and PPARγ2 genes in adipose tissue (AT) of obese women. It was conducted a parallel, randomized, controlled, single-blind study with dietary intervention (DI) for 60 days, where 32 women with obesity classes I and II were distributed into three groups: G1 = diet rich in n-3 PUFA and n-6 (n = 10); G2 = MUFA-rich diet (n = 11); and G3 = control (n = 11). For G1 and G2 were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered. In order to achieve the desired intake of unsaturated FA, both groups received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner (G1 = mix of virgin olive oil [VOO] and soybean oil [SO], overall of 35.2g to 52.8g / day; G2 = VOO, overall of 35.2g to 50.6 g / day), besides gelatin capsules (G1 = 2 g of fish oil / day; G2 = 1 capsule of 1g of SO / day). G3 was instructed to keep their eating habits and consuming placebos (1 sachet of 2g of SO and 1 capsule of 1g of SO / day).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Dietary Lipid Modulation in Energy Expenditure, Body Composition, Obesity-related Biomarkers and Gene Expression of Peroxisome Proliferator-Activated Receptors Alpha and Gamma 2 in Adipose Tissue of Obese Women
Study Start Date : February 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fats

Arm Intervention/treatment
Experimental: Group 1 - diet rich in n-3 and n-6 PUFA

Assigned intervention: The dietary intervention was conducted by 60 days. Were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered.

Group 1 received diet rich in n-3 and n-6 polyunsaturated fatty acids (PUFA). The volunteers were asked to consume daily a mixture of virgin olive oil and soybean oil, totaling 35.2g to 52.8g, and 2 g of fish oil.

Dietary Supplement: Group 1 - diet rich in n-3 and n-6 PUFA
In order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days.

Experimental: Group 2 - diet rich in MUFA

Assigned intervention: The dietary intervention was conducted by 60 days. Were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered.

Group 2 received diet rich in monounsaturated fatty acids (MUFA). The volunteers were asked to consume daily virgin olive oil, totaling 35.2g to 50.6g, and 1 capsule of 1g of soybean oil.

Dietary Supplement: Group 2 - diet rich in MUFA
In order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days.

Experimental: Group 3 - Placebo group
Placebo group was instructed to keep their eating habits and consuming 1 sachet of 2g of soybean oil and 1 capsule of 1g of soybean oil by day.
Dietary Supplement: Group 3 - Placebo group
Placebo group was instructed to keep their eating habits and consuming placebo for 60 days.




Primary Outcome Measures :
  1. Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese women [ Time Frame: Change from baseline energy expenditure at 2 months ]
    The energy expenditure was evaluated by indirect calorimetry (Vmax Encore 29 Systems®)


Secondary Outcome Measures :
  1. Effects of modulation of PUFA and MUFA in body weight of obese women [ Time Frame: Change from baseline loss of body weight at 2 months ]
  2. Effects of modulation of PUFA and MUFA in body composition of obese women [ Time Frame: Change from baseline body composition at 2 months ]
    The body composition was evaluated by electrical bioimpedance

  3. Effects of modulation of PUFA and MUFA in feeding behavior of obese women [ Time Frame: Change from baseline feeding behavior at 2 months ]
    Feeding behavior was evaluated by Three Factor Eating Questionnaire

  4. Effects of modulation of PUFA and MUFA in gene expression of obese women [ Time Frame: Change from baseline gene expression at 2 months ]
    Gene expression of PPARα and PPARγ2 in adipose tissue

  5. Effects of modulation of PUFA and MUFA in blood glucose of obese women [ Time Frame: Change from baseline blood glucose at 2 months ]
  6. Effects of modulation of PUFA and MUFA in blood insulin of obese women [ Time Frame: Change from baseline blood insulin at 2 months ]
  7. Effects of modulation of PUFA and MUFA in insulin resistance of obese women [ Time Frame: Change from baseline insulin resistance at 2 months ]
    Insulin resistance was evaluated by Homeostasis Model Assessment

  8. Effects of modulation of PUFA and MUFA in insulin sensitivity of obese women [ Time Frame: Change from baseline insulin sensitivity at 2 months ]
    Insulin resistance was evaluated by Quantitative Insulin Sensitivity Check Index

  9. Effects of modulation of PUFA and MUFA in total cholesterol and fractions of obese women [ Time Frame: Change from baseline total cholesterol and fractions at 2 months ]
    total cholesterol and fractions and triglycerides

  10. Effects of modulation of PUFA and MUFA in adiponectin of obese women [ Time Frame: Change from baseline adiponectin at 2 months ]
    serum adiponectin

  11. Effects of modulation of PUFA and MUFA in leptin of obese women [ Time Frame: Change from baseline leptin at 2 months ]
    serum leptin

  12. Effects of modulation of PUFA and MUFA in TNF alpha of obese women [ Time Frame: Change from baseline TNF alpha at 2 months ]
    serum TNF alpha

  13. Effects of modulation of PUFA and MUFA in interleukin 6 of obese women [ Time Frame: Change from baseline interleukin 6 at 2 months ]
    serum interleukin 6



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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • obesity grades I and II (body mass index between 30 and 39,99 kg/m2);
  • completion of basic education (former 4th primary series).

Exclusion Criteria:

  • menopausal;
  • weight loss more than three kilograms (3 kg) in the last three months;
  • diagnosis of diabetes mellitus, heart disease, hypertension, nephropathy, liver diseases , thyroid dysfunction; gastrointestinal disorders , acquired immunodeficiency syndrome or cancer;
  • cholecystectomy in the past 12 months and other recent surgeries;
  • pregnancy or lactation;
  • smokers;
  • drugs to lipid-lowering, diabetes, hypertension, depression, or obesity;
  • food history of allergy or intolerance to vegetable oils (olive oil, soy or canola), fish oil, fish and / or seafood.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656940


Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
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Study Director: Eliane L Rosado, Doctor UFRJ

Publications:

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Responsible Party: Vanessa Chaia Kaippert, Doctor, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02656940     History of Changes
Other Study ID Numbers: 778/10 Parecer CEP
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

Keywords provided by Vanessa Chaia Kaippert, Universidade Federal do Rio de Janeiro:
obesity
lipids
energy expenditure
gene expression

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms