Dietary Lipids, Energy Expenditure and Obesity Biomarkers

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - diet rich in n-3 and n-6 PUFA<br>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<br>* 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.<br>|
| Experimental: Group 2 - diet rich in MUFA<br>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<br>* 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.<br>|
| Experimental: Group 3 - Placebo group<br>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<br>* Placebo group was instructed to keep their eating habits and consuming placebo for 60 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese women | 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 |  | Change from baseline loss of body weight at 2 months | 
| Effects of modulation of PUFA and MUFA in body composition of obese women | 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 | 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 | 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 |  | 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 insulin resistance of obese women | 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 | 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 | 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 | serum adiponectin | Change from baseline adiponectin at 2 months | 
| Effects of modulation of PUFA and MUFA in leptin of obese women | serum leptin | Change from baseline leptin at 2 months | 
| Effects of modulation of PUFA and MUFA in TNF alpha of obese women | serum TNF alpha | Change from baseline TNF alpha at 2 months | 
| Effects of modulation of PUFA and MUFA in interleukin 6 of obese women | serum interleukin 6 | Change from baseline interleukin 6 at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, lipids, energy expenditure, gene expression