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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00718874

First Posted: July 21, 2008

Last Update Posted: April 19, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Thrasher Research Fund

Information provided by (Responsible Party):

Krista Casazza, University of Alabama at Birmingham

Purpose

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	Intervention
Obesity Type 2 Diabetes	Other: Dietary


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention
Official Title:	Dietary Intervention to Improve Insulin Dynamics During the Pubertal Transition

Resource links provided by NLM:

MedlinePlus related topics: African American Health

U.S. FDA Resources

Further study details as provided by Krista Casazza, University of Alabama at Birmingham:

Primary Outcome Measures:

decreased insulin secretion [ Time Frame: 25 weeks ]

Secondary Outcome Measures:

decreased markers of inflammation; decreased estradiol concentration [ Time Frame: 25 weeks ]


Enrollment:	30
Study Start Date:	June 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	9 Years to 15 Years (Child)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718874

Locations


United States, Alabama
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

More Information


Responsible Party:	Krista Casazza, Krista R. Casazza PhD, RD/Assistant Professor, UAB, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00718874 History of Changes
Other Study ID Numbers:	F080605012
First Submitted:	July 18, 2008
First Posted:	July 21, 2008
Last Update Posted:	April 19, 2012
Last Verified:	April 2012

Keywords provided by Krista Casazza, University of Alabama at Birmingham:


obesity, puberty, diabetes,insulin dynamics

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