PrOtein and WEight Loss in teenageRs (POWER)

Effects of Varied Macronutrient Composition on Weight Loss in Obese Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Behavioral: Energy Restriction; Behavioral: Higher protein; Behavioral: Lower Protein

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Higher protein and energy restriction; Participants in this arm will consume 30% of energy as protein with 25% energy restriction.	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.; Behavioral: 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.
Experimental: Lower protein and energy restriction; Participants in this arm will consume 15% of energy as protein with 25% energy restriction.	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BMI Z-Score	up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Ratings of Appetite		Baseline and Week 12
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

Other Outcome Measures

Outcome Measure	Time Frame
Glucose	Baseline and Week 12
Insulin	Baseline and Week 12
Cholesterol	Baseline and Week 12
Triglycerides	Baseline and Week 12
Blood Pressure	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: John W Apolzan, PhD, Pennington Biomedical

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Estimate): January 11, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: childhood obesity; anthropometry; Adolescent obesity; body weights and measures
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Pediatric Obesity; Weight Loss
• Other Study ID Numbers: PBRC 2014-014