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

Tangier Disease Clinical Trial

Official title:

High Protein Diet , Adiponectin and Inflammatory Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886495
• Other study ID #: high protein diet in children
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2013
• Last updated: June 25, 2013
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: June 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Body Mass Index Quantitative Trait Locus 5 Disorder
• Tangier Disease

Intervention

Other:
• nutrition intervention

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences Leila Azadbakht, Phd	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adiponectin (mcg/ml)	amount of adiponectin	10 weeks	Yes
Secondary	interlukine 6 (mcg/ml)		10 weeks	Yes
Secondary	tumor necrosis factor alpha (ng/ml)		10 weeks	Yes
Secondary	C reactive protein (mcg/ml)		10 weeks	Yes
Secondary	fibrinogen (mcg/ml)		10 weeks	Yes