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临床试验/NCT02656940
NCT02656940已完成不适用

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

Universidade Federal do Rio de Janeiro0 个研究点目标入组 32 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
主要终点
Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese women

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • obesity grades I and II (body mass index between 30 and 39,99 kg/m2);
  • completion of basic education (former 4th primary series).

排除标准

  • 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;
  • 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.

结局指标

主要结局

Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese women

时间窗: Change from baseline energy expenditure at 2 months

The energy expenditure was evaluated by indirect calorimetry (Vmax Encore 29 Systems®)

次要结局

  • Effects of modulation of PUFA and MUFA in body composition of obese women(Change from baseline body composition at 2 months)
  • Effects of modulation of PUFA and MUFA in gene expression of obese women(Change from baseline gene expression at 2 months)
  • Effects of modulation of PUFA and MUFA in leptin of obese women(Change from baseline leptin at 2 months)
  • Effects of modulation of PUFA and MUFA in interleukin 6 of obese women(Change from baseline interleukin 6 at 2 months)
  • Effects of modulation of PUFA and MUFA in insulin sensitivity of obese women(Change from baseline insulin sensitivity at 2 months)
  • Effects of modulation of PUFA and MUFA in adiponectin of obese women(Change from baseline adiponectin at 2 months)
  • 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)
  • Effects of modulation of PUFA and MUFA in insulin resistance of obese women(Change from baseline insulin resistance 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 total cholesterol and fractions of obese women(Change from baseline total cholesterol and fractions at 2 months)
  • Effects of modulation of PUFA and MUFA in TNF alpha of obese women(Change from baseline TNF alpha at 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa Chaia Kaippert

Doctor

Universidade Federal do Rio de Janeiro

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