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

Dietary Intervention to Improve Insulin Dynamics During the Pubertal Transition

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00718874

Acronym

PRIMO

Enrollment

Registered

2008-07-21

Start date

2008-06-30

Completion date

2010-06-30

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes

Keywords

obesity, puberty, diabetes,insulin dynamics

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)

Interventions

OTHERDietary

modification of macronutrient content

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

9 Years to 15 Years

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

Design outcomes

Primary

Measure	Time frame
decreased insulin secretion	25 weeks

Secondary

Measure	Time frame
decreased markers of inflammation; decreased estradiol concentration	25 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026