Dietary Lipids, Energy Expenditure and Obesity Biomarkers

Not Applicable

Completed

• Conditions: Obesity
• Interventions: 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

• Registration Number: NCT02656940
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-02
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Status Verified: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-12
• Last Update Submitted: 2016-01-12
• Study First Posted: 2016-01-15
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - diet rich in n-3 and n-6 PUFA	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.
Group 2 - diet rich in MUFA	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.
Group 3 - Placebo group	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.

Primary Outcome Measures

Name	Time	Method
Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese women	Change from baseline energy expenditure at 2 months	The energy expenditure was evaluated by indirect calorimetry (Vmax Encore 29 Systems®)

Secondary Outcome Measures

Name	Time	Method
Effects of modulation of PUFA and MUFA in body composition of obese women	Change from baseline body composition at 2 months	The body composition was evaluated by electrical bioimpedance
Effects of modulation of PUFA and MUFA in gene expression of obese women	Change from baseline gene expression at 2 months	Gene expression of PPARα and PPARγ2 in adipose tissue
Effects of modulation of PUFA and MUFA in leptin of obese women	Change from baseline leptin at 2 months	serum leptin
Effects of modulation of PUFA and MUFA in interleukin 6 of obese women	Change from baseline interleukin 6 at 2 months	serum interleukin 6
Effects of modulation of PUFA and MUFA in insulin sensitivity of obese women	Change from baseline insulin sensitivity at 2 months	Insulin resistance was evaluated by Quantitative Insulin Sensitivity Check Index
Effects of modulation of PUFA and MUFA in adiponectin of obese women	Change from baseline adiponectin at 2 months	serum adiponectin
Effects of modulation of PUFA and MUFA in body weight of obese women	Change from baseline loss of body weight at 2 months
Effects of modulation of PUFA and MUFA in feeding behavior of obese women	Change from baseline feeding behavior at 2 months	Feeding behavior was evaluated by Three Factor Eating Questionnaire
Effects of modulation of PUFA and MUFA in insulin resistance of obese women	Change from baseline insulin resistance at 2 months	Insulin resistance was evaluated by Homeostasis Model Assessment
Effects of modulation of PUFA and MUFA in blood glucose of obese women	Change from baseline blood glucose at 2 months
Effects of modulation of PUFA and MUFA in blood insulin of obese women	Change from baseline blood insulin at 2 months
Effects of modulation of PUFA and MUFA in total cholesterol and fractions of obese women	Change from baseline total cholesterol and fractions at 2 months	total cholesterol and fractions and triglycerides
Effects of modulation of PUFA and MUFA in TNF alpha of obese women	Change from baseline TNF alpha at 2 months	serum TNF alpha