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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT00718874

Collaborator

Thrasher Research Fund (Other)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Obesity Type 2 Diabetes	Other: Dietary	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Dietary Intervention to Improve Insulin Dynamics During the Pubertal Transition

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A, 1 low-carbohydrate (42%)	Other: Dietary modification of macronutrient content
Experimental: A,2 standard carbohydrate (55%) based on ADA recommendations	Other: Dietary modification of macronutrient content

Arm

Intervention/Treatment

Experimental: A, 1

low-carbohydrate (42%)

Other: Dietary

modification of macronutrient content

Experimental: A,2

standard carbohydrate (55%) based on ADA recommendations

Other: Dietary

modification of macronutrient content

Outcome Measures

Primary Outcome Measures

decreased insulin secretion [25 weeks]

Secondary Outcome Measures

decreased markers of inflammation; decreased estradiol concentration [25 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 15 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

African American girls aged 9-14,
Overweight < 90th percentile

Exclusion Criteria:

On medications known to affect metabolism prior disease diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham
Thrasher Research Fund

Investigators

Principal Investigator: Krista Casazza, PhD, RD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Krista Casazza, Krista R. Casazza PhD, RD/Assistant Professor, UAB, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00718874

Other Study ID Numbers:

F080605012

First Posted:

Jul 21, 2008

Last Update Posted:

Nov 25, 2019

Last Verified:

Nov 1, 2019

Keywords provided by Krista Casazza, Krista R. Casazza PhD, RD/Assistant Professor, UAB, University of Alabama at Birmingham

obesity, puberty, diabetes,insulin dynamics

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Nov 25, 2019