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

NCT ID: NCT00718874

Last Updated: 2019-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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Obesity Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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A, 1

low-carbohydrate (42%)

Group Type EXPERIMENTAL

Dietary

Intervention Type OTHER

modification of macronutrient content

A,2

standard carbohydrate (55%) based on ADA recommendations

Group Type EXPERIMENTAL

Dietary

Intervention Type OTHER

modification of macronutrient content

Interventions

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Dietary

modification of macronutrient content

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* On medications known to affect metabolism prior disease diagnosis
Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Thrasher Research Fund

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Krista Casazza

Krista R. Casazza PhD, RD/Assistant Professor, UAB

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Krista Casazza, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F080605012

Identifier Type: -

Identifier Source: org_study_id

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