Dietary Lipids, Energy Expenditure and Obesity Biomarkers

January 12, 2016 updated by: Vanessa Chaia Kaippert, Universidade Federal do Rio de Janeiro

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®)
Change from baseline energy expenditure at 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline loss of body weight at 2 months
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
Change from baseline body composition at 2 months
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
Change from baseline feeding behavior at 2 months
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
Change from baseline gene expression at 2 months
Effects of modulation of PUFA and MUFA in blood glucose of obese women
Time Frame: Change from baseline blood glucose at 2 months
Change from baseline blood glucose at 2 months
Effects of modulation of PUFA and MUFA in blood insulin of obese women
Time Frame: Change from baseline blood insulin at 2 months
Change from baseline blood insulin at 2 months
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
Change from baseline insulin resistance at 2 months
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
Change from baseline insulin sensitivity at 2 months
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
Change from baseline total cholesterol and fractions at 2 months
Effects of modulation of PUFA and MUFA in adiponectin of obese women
Time Frame: Change from baseline adiponectin at 2 months
serum adiponectin
Change from baseline adiponectin at 2 months
Effects of modulation of PUFA and MUFA in leptin of obese women
Time Frame: Change from baseline leptin at 2 months
serum leptin
Change from baseline leptin at 2 months
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
Change from baseline TNF alpha at 2 months
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
Change from baseline interleukin 6 at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Study Director: Eliane L Rosado, Doctor, UFRJ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 12, 2016

First Posted (ESTIMATE)

January 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 778/10 Parecer CEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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