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Dietary Lipids, Energy Expenditure and Obesity Biomarkers

U

Universidade Federal do Rio de Janeiro

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: Group 2 - diet rich in MUFA
Dietary Supplement: Group 3 - Placebo group
Dietary Supplement: Group 1 - diet rich in n-3 and n-6 PUFA

Study type

Interventional

Funder types

Other

Identifiers

NCT02656940
778/10 Parecer CEP

Details and patient eligibility

About

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

Full 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).

Enrollment

32 patients

Sex

Female

Ages

20 to 39 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 3 patient groups

Group 1 - diet rich in n-3 and n-6 PUFA
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Group 1 - diet rich in n-3 and n-6 PUFA
Group 2 - diet rich in MUFA
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Group 2 - diet rich in MUFA
Group 3 - Placebo group
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Group 3 - Placebo group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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