A Specialized Diet for the Unique Metabolic Characteristics of Peripubertal African American Girls

Obesity Clinical Trial

— PRIMO  

Official title:

Dietary Intervention to Improve Insulin Dynamics During the Pubertal Transition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718874
• Other study ID #: F080605012
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: November 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A diet (42% carbohydrate) specialized to the unique metabolic characteristics of peripubertal African AMerican girls (hyperinsulinemic, low insulin sensitive) will be more effective in maintaining glucose and insulin homeostasis compared to a standard diet (55% carbohydrate)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 15 Years

Eligibility

Inclusion Criteria:

• African American girls aged 9-14,

• Overweight < 90th percentile

Exclusion Criteria:

• On medications known to affect metabolism prior disease diagnosis

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

Intervention

Other:
• Dietary
modification of macronutrient content

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decreased insulin secretion		25 weeks
Secondary	decreased markers of inflammation; decreased estradiol concentration		25 weeks