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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Type 2 Diabetes | Other: Dietary | Not Applicable |
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 |

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
|
- decreased insulin secretion [ Time Frame: 25 weeks ]
- decreased markers of inflammation; decreased estradiol concentration [ Time Frame: 25 weeks ]

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

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
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Krista Casazza, PhD, RD | University of Alabama at Birmingham |
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 |