Study Results
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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COMPLETED
NA
32 participants
INTERVENTIONAL
2014-03-31
2015-07-31
Brief Summary
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Detailed Description
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It is hypothesized that participants randomly assigned to the higher protein dietary treatment will lose more weight based on BMI-Z score over 12 weeks compared to participants in the lower dietary protein treatment.
Aim 2 is to test if changes in subjective ratings of appetite differ by dietary treatment (i.e. protein intake).
It is hypothesized that participants in the higher protein intervention will report a decrease in hunger and an increase in fullness compared to participants in the lower protein intervention.
Aim 3 is to test if change in the hexosamine biosynthetic pathway (HBP) measured at the rate limiting step of glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) differ by dietary treatment.
It is hypothesized that participants randomly assigned to the higher protein dietary treatment will have decreased change from baseline levels of GFAT and glycosylation (OGT) due to decreased carbohydrate intake compared to the lower protein treatment.
Exploratory Aims: As exploratory aims, the investigators will test if the higher protein or lower protein dietary treatments differentially alter glucose, insulin, cholesterol, and triglycerides (markers of the metabolic syndrome).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Higher protein and energy restriction
Participants in this arm will consume 30% of energy as protein with 25% energy restriction.
Energy Restriction
Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity.
Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity.
Higher protein
The higher protein group will be instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively.
Lower protein and energy restriction
Participants in this arm will consume 15% of energy as protein with 25% energy restriction.
Energy Restriction
Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity.
Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity.
Lower Protein
The lower protein group will be instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively.
Interventions
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Energy Restriction
Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity.
Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity.
Higher protein
The higher protein group will be instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively.
Lower Protein
The lower protein group will be instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively.
Eligibility Criteria
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Inclusion Criteria
* Be between the ages of 12 and 17, inclusive
* Be at or above the 85th BMI percentile (a number calculated from the participants height, weight, sex, and date of birth)
* Be willing to fast for 12 hours prior to clinic study visits 2 and 4
* Be willing to participate in the research study
Exclusion Criteria
* Has HIV or AIDS
* Has uncontrolled CVD or arrhythmia
* Has Type I or Type II diabetes.
* Is unable or unwilling to complete the study procedures
Medications:
* Diuretics
* Beta-blocker
* Weight loss medications, diet pills
* Anti-inflammatory drugs (corticosteroid/anabolic steroid/NSAID)
* Antipsychotic medications
* Other medications that may affect fluid balance or weight
Lifestyle:
• Plans to move out of the study area within the next 4 months, or plan to be out of the study area for more than 3 weeks during the course of the study.
12 Years
17 Years
ALL
Yes
Sponsors
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Pennington Biomedical Research Center
OTHER
Responsible Party
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John Apolzan
Assistant Professor
Principal Investigators
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John W Apolzan, PhD
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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Other Identifiers
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PBRC 2014-014
Identifier Type: -
Identifier Source: org_study_id
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