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Dietary Lipids, Energy Expenditure and Obesity Biomarkers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02656940
Enrollment
32
Registered
2016-01-15
Start date
2013-02-28
Completion date
2014-07-31
Last updated
2016-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, lipids, energy expenditure, gene expression

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).

Interventions

DIETARY_SUPPLEMENTGroup 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.

DIETARY_SUPPLEMENTGroup 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.

DIETARY_SUPPLEMENTGroup 3 - Placebo group

Placebo group was instructed to keep their eating habits and consuming placebo for 60 days.

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese womenChange from baseline energy expenditure at 2 monthsThe energy expenditure was evaluated by indirect calorimetry (Vmax Encore 29 Systems®)

Secondary

MeasureTime frameDescription
Effects of modulation of PUFA and MUFA in body composition of obese womenChange from baseline body composition at 2 monthsThe body composition was evaluated by electrical bioimpedance
Effects of modulation of PUFA and MUFA in feeding behavior of obese womenChange from baseline feeding behavior at 2 monthsFeeding behavior was evaluated by Three Factor Eating Questionnaire
Effects of modulation of PUFA and MUFA in gene expression of obese womenChange from baseline gene expression at 2 monthsGene expression of PPARα and PPARγ2 in adipose tissue
Effects of modulation of PUFA and MUFA in blood glucose of obese womenChange from baseline blood glucose at 2 months
Effects of modulation of PUFA and MUFA in blood insulin of obese womenChange from baseline blood insulin at 2 months
Effects of modulation of PUFA and MUFA in insulin resistance of obese womenChange from baseline insulin resistance at 2 monthsInsulin resistance was evaluated by Homeostasis Model Assessment
Effects of modulation of PUFA and MUFA in body weight of obese womenChange from baseline loss of body weight at 2 months
Effects of modulation of PUFA and MUFA in total cholesterol and fractions of obese womenChange from baseline total cholesterol and fractions at 2 monthstotal cholesterol and fractions and triglycerides
Effects of modulation of PUFA and MUFA in adiponectin of obese womenChange from baseline adiponectin at 2 monthsserum adiponectin
Effects of modulation of PUFA and MUFA in leptin of obese womenChange from baseline leptin at 2 monthsserum leptin
Effects of modulation of PUFA and MUFA in TNF alpha of obese womenChange from baseline TNF alpha at 2 monthsserum TNF alpha
Effects of modulation of PUFA and MUFA in interleukin 6 of obese womenChange from baseline interleukin 6 at 2 monthsserum interleukin 6
Effects of modulation of PUFA and MUFA in insulin sensitivity of obese womenChange from baseline insulin sensitivity at 2 monthsInsulin resistance was evaluated by Quantitative Insulin Sensitivity Check Index

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026