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

This study has been completed.

Sponsor:

Collaborator:

Thrasher Research Fund

Information provided by (Responsible Party):

Krista Casazza, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00718874

First received: July 18, 2008

Last updated: April 18, 2012

Last verified: April 2012

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	Dietary Intervention to Improve Insulin Dynamics During the Pubertal Transition

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

Primary Outcome Measures:

decreased insulin secretion [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

decreased markers of inflammation; decreased estradiol concentration [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	9 Years to 15 Years (Child)
Genders 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

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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	July 18, 2008
Last Updated:	April 18, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:


obesity, puberty, diabetes,insulin dynamics

ClinicalTrials.gov processed this record on September 23, 2016

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