Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children

June 25, 2013 updated by: Leila Azadbakht, Isfahan University of Medical Sciences

High Protein Diet , Adiponectin and Inflammatory Factors

The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory factors among overweight and obese children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

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

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

6 years to 11 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 85th
  • age of 6-11 years
  • no history of chronic diseases
  • taken medications

Exclusion Criteria:

  • do not prescribe their diet
  • mental retardation

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: nutrition intervention
high protein diet
Other: nutrition intervention
Other Names:
  • high protein diet
NO_INTERVENTION: control diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adiponectin (mcg/ml)
Time Frame: 10 weeks
amount of adiponectin
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
interlukine 6 (mcg/ml)
Time Frame: 10 weeks
10 weeks
tumor necrosis factor alpha (ng/ml)
Time Frame: 10 weeks
10 weeks
C reactive protein (mcg/ml)
Time Frame: 10 weeks
10 weeks
fibrinogen (mcg/ml)
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

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

Sponsor

Isfahan University of Medical Sciences

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

September 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (ESTIMATE)

June 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • high protein diet in children

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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