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

March 13, 2014 updated by: Grazielle Vilas Boas Huguenin, Universidade Federal do Rio de Janeiro

Effect of Hypocaloric Diet on Biomarkers of Metabolic Profile, Insulin Resistance and Body Composition in Women With Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941- 902
        • Federal University of Rio de Janeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-calorie diet
The subjects were prescribed a daily energy intake 500 kcal lower than the estimated energy requirement.
Other: Low-calorie diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Change from baseline at 3rd month
Change from baseline weight (Kg) at 3rd month.
Change from baseline at 3rd month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance markers
Time Frame: Change from baseline at 3rd month
Change from baseline fasting glucose and insulin, homeostasis model assessment-insulin resistance and quantitative insulin sensitivity check index at 3rd month, samples were stored at -20 degrees.
Change from baseline at 3rd month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adipokines
Time Frame: Change from baseline at 3rd month
The change from baseline leptin and adiponectin at 3rd month, samples were stored at -20 degrees
Change from baseline at 3rd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Rio de Janeiro State University
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0535.0.000.325-08
  • U1111-1154-4418 (Other Identifier: Universal trial number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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