Clinical trial NCT02656940: Dietary Lipids, Energy Expenditure and Obesity Biomarkers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
lipids
energy expenditure
gene expression
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 32
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese women
timeFrame: Change from baseline energy expenditure at 2 months
Secondary outcomes:
measure: Effects of modulation of PUFA and MUFA in body weight of obese women
timeFrame: Change from baseline loss of body weight at 2 months
measure: Effects of modulation of PUFA and MUFA in body composition of obese women
timeFrame: Change from baseline body composition at 2 months
measure: Effects of modulation of PUFA and MUFA in feeding behavior of obese women
timeFrame: Change from baseline feeding behavior at 2 months
measure: Effects of modulation of PUFA and MUFA in gene expression of obese women
timeFrame: Change from baseline gene expression at 2 months
measure: Effects of modulation of PUFA and MUFA in blood glucose of obese women
timeFrame: Change from baseline blood glucose at 2 months
measure: Effects of modulation of PUFA and MUFA in blood insulin of obese women
timeFrame: Change from baseline blood insulin at 2 months
measure: Effects of modulation of PUFA and MUFA in insulin resistance of obese women
timeFrame: Change from baseline insulin resistance at 2 months
measure: Effects of modulation of PUFA and MUFA in insulin sensitivity of obese women
timeFrame: Change from baseline insulin sensitivity at 2 months
measure: Effects of modulation of PUFA and MUFA in total cholesterol and fractions of obese women
timeFrame: Change from baseline total cholesterol and fractions at 2 months
measure: Effects of modulation of PUFA and MUFA in adiponectin of obese women
timeFrame: Change from baseline adiponectin at 2 months
measure: Effects of modulation of PUFA and MUFA in leptin of obese women
timeFrame: Change from baseline leptin at 2 months
measure: Effects of modulation of PUFA and MUFA in TNF alpha of obese women
timeFrame: Change from baseline TNF alpha at 2 months
measure: Effects of modulation of PUFA and MUFA in interleukin 6 of obese women
timeFrame: Change from baseline interleukin 6 at 2 months
Other outcomes:
Locations:
Study officials:
affiliation: UFRJ
name: Eliane L Rosado, Doctor
role: STUDY_DIRECTOR
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