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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:


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