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

The University of Alabama at Birmingham

Status: Completed

Conditions: Obesity; Type 2 Diabetes

Treatments: Other: Dietary

Study type: Interventional

Funder types: Other

Identifiers

NCT00718874

F080605012

Details and patient eligibility

About

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)

Enrollment: 30 patients

Sex: Female

Ages: 9 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• African American girls aged 9-14,
• Overweight < 90th percentile

Exclusion criteria

• On medications known to affect metabolism prior disease diagnosis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

A, 1

Experimental group

Description:

low-carbohydrate (42%)

Treatment:

Other: Dietary

A,2

Experimental group

Description:

standard carbohydrate (55%) based on ADA recommendations

Treatment:

Other: Dietary