PrOtein and WEight Loss in teenageRs

Pediatric Obesity Clinical Trial

— POWER  

Official title:

Effects of Varied Macronutrient Composition on Weight Loss in Obese Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079831
• Other study ID #: PBRC 2014-014
• Status: Completed
• Phase: N/A
• First received: March 3, 2014
• Last updated: January 7, 2016
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the proposed study is to provide important data on weight loss efficacy in overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The investigators hypothesize that the higher protein diet will result in greater weight loss due to increased satiety and better dietary adherence.

Description:

Aim 1 is to test the efficacy of a personalized higher protein weight loss intervention compared to a lower protein intervention which use the USDA MyPlate nutrition guide.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Be male or female

• 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:

• Health Conditions:

• 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

• Participant may not qualify for this study based on other exclusion criteria not listed. The study coordinator will go over this information in detail.

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.

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity
• Weight Loss

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glucose		Baseline and Week 12
Other	Insulin		Baseline and Week 12
Other	Cholesterol		Baseline and Week 12
Other	Triglycerides		Baseline and Week 12
Other	Blood Pressure		Baseline and Week 12
Primary	BMI Z-Score		up to Week 12
Secondary	Subjective Ratings of Appetite		Baseline and Week 12
Secondary	Hexosamine Biosynthetic Pathway	glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) measurement	Baseline and Week 12