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Completed

NCT Number: NCT02656940

Dietary Lipids, Energy Expenditure and Obesity Biomarkers

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

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Key information

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group 1 - diet rich in n-3 and n-6 PUFA

Dietary Supplement

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.

Group 2 - diet rich in MUFA

Dietary Supplement

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.

Group 3 - Placebo group

Dietary Supplement

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

Primary outcomes

  1. 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®)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Effects of modulation of PUFA and MUFA in blood glucose of obese women

    Time frame: Change from baseline blood glucose at 2 months

  6. Effects of modulation of PUFA and MUFA in blood insulin of obese women

    Time frame: Change from baseline blood insulin at 2 months

  7. 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

  8. 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

  9. 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

  10. Effects of modulation of PUFA and MUFA in adiponectin of obese women

    Time frame: Change from baseline adiponectin at 2 months

    serum adiponectin

  11. Effects of modulation of PUFA and MUFA in leptin of obese women

    Time frame: Change from baseline leptin at 2 months

    serum leptin

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 15, 2016
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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