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

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ClinicalTrials.gov Identifier: NCT00718874
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : April 19, 2012
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Krista Casazza, University of Alabama at Birmingham

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : June 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Primary Outcome Measures :
  1. decreased insulin secretion [ Time Frame: 25 weeks ]

Secondary Outcome Measures :
  1. decreased markers of inflammation; decreased estradiol concentration [ Time Frame: 25 weeks ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: July 21, 2008    Key Record Dates
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