Effect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome

NCT ID: NCT02087709

Last Updated: 2014-03-14

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to evaluate the effect of a hypocaloric diet on biomarkers associated with insulin resistance, metabolic profile and body composition in women with Metabolic Syndrome.

Detailed Description

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Conditions

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Weight Loss Insulin Resistance Adipokines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-calorie diet

The subjects were prescribed a daily energy intake 500 kcal lower than the estimated energy requirement.

Group Type EXPERIMENTAL

Low-calorie diet

Intervention Type OTHER

Interventions

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Low-calorie diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI of 30-34.9 kg/m2, diagnostic of metabolic syndrome based on National Cholesterol Education Panel ATPIII (2002)

Exclusion Criteria

* Diabetes mellitus, non-treated thyroid disease, treatment with lipid-lowering drugs and glucocorticoids or weight loss treatment within the previous 3 months.
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rio de Janeiro State University

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Grazielle Vilas Boas Huguenin

Mrs

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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U1111-1154-4418

Identifier Type: OTHER

Identifier Source: secondary_id

0535.0.000.325-08

Identifier Type: -

Identifier Source: org_study_id

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