Dietary Lipids, Energy Expenditure and Obesity Biomarkers

NCT ID: NCT02656940

Last Updated: 2016-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

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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

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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).

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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.

Group Type EXPERIMENTAL

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

Intervention Type 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

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.

Group Type EXPERIMENTAL

Group 2 - diet rich in MUFA

Intervention Type 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

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.

Group Type EXPERIMENTAL

Group 3 - Placebo group

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Group 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.

Intervention Type DIETARY_SUPPLEMENT

Group 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.

Intervention Type DIETARY_SUPPLEMENT

Group 3 - Placebo group

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Chaia Kaippert

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eliane L Rosado, Doctor

Role: STUDY_DIRECTOR

UFRJ

References

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Clevenger HC, Stevenson JL, Cooper JA. Metabolic responses to dietary fatty acids in obese women. Physiol Behav. 2015 Feb;139:73-9. doi: 10.1016/j.physbeh.2014.11.022. Epub 2014 Nov 13.

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PMID: 14694208 (View on PubMed)

Guri AJ, Hontecillas R, Bassaganya-Riera J. Dietary modulators of peroxisome proliferator-activated receptors: implications for the prevention and treatment of metabolic syndrome. J Nutrigenet Nutrigenomics. 2008;1(3):126-35. doi: 10.1159/000112460. Epub 2008 Feb 20.

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Krebs JD, Browning LM, McLean NK, Rothwell JL, Mishra GD, Moore CS, Jebb SA. Additive benefits of long-chain n-3 polyunsaturated fatty acids and weight-loss in the management of cardiovascular disease risk in overweight hyperinsulinaemic women. Int J Obes (Lond). 2006 Oct;30(10):1535-44. doi: 10.1038/sj.ijo.0803309. Epub 2006 Mar 21.

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Liao FH, Liou TH, Shieh MJ, Chien YW. Effects of different ratios of monounsaturated and polyunsaturated fatty acids to saturated fatty acids on regulating body fat deposition in hamsters. Nutrition. 2010 Jul-Aug;26(7-8):811-7. doi: 10.1016/j.nut.2009.09.009. Epub 2009 Dec 22.

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Mejia-Barradas CM, Del-Rio-Navarro BE, Dominguez-Lopez A, Campos-Rodriguez R, Martinez-Godinez Md, Rojas-Hernandez S, Lara-Padilla E, Abarca-Rojano E, Miliar-Garcia A. The consumption of n-3 polyunsaturated fatty acids differentially modulates gene expression of peroxisome proliferator-activated receptor alpha and gamma and hypoxia-inducible factor 1 alpha in subcutaneous adipose tissue of obese adolescents. Endocrine. 2014 Feb;45(1):98-105. doi: 10.1007/s12020-013-9941-y. Epub 2013 Apr 2.

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van Dijk SJ, Feskens EJ, Bos MB, Hoelen DW, Heijligenberg R, Bromhaar MG, de Groot LC, de Vries JH, Muller M, Afman LA. A saturated fatty acid-rich diet induces an obesity-linked proinflammatory gene expression profile in adipose tissue of subjects at risk of metabolic syndrome. Am J Clin Nutr. 2009 Dec;90(6):1656-64. doi: 10.3945/ajcn.2009.27792. Epub 2009 Oct 14.

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Lopes MCODS, Kaippert VC, Crovesy L, de Carvalho DP, Rosado EL. Monounsaturated fat-rich diet reduces body adiposity in women with obesity, but does not influence energy expenditure and substrate oxidation: a parallel randomized controlled clinical trial. Eur J Clin Nutr. 2024 Apr;78(4):335-343. doi: 10.1038/s41430-024-01401-3. Epub 2024 Jan 12.

Reference Type DERIVED
PMID: 38216647 (View on PubMed)

Other Identifiers

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778/10 Parecer CEP

Identifier Type: -

Identifier Source: org_study_id

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