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OpenTrials
Completed

NCT Number: NCT02079831

PrOtein and WEight Loss in teenageRs

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Energy restriction

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. BMI Z-Score

    Time frame: up to Week 12

Secondary outcomes

  1. Subjective Ratings of Appetite

    Time frame: Baseline and Week 12

  2. Hexosamine Biosynthetic Pathway

    Time frame: Baseline and Week 12

    glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) measurement

Other outcomes

  1. Glucose

    Time frame: Baseline and Week 12

  2. Insulin

    Time frame: Baseline and Week 12

  3. Cholesterol

    Time frame: Baseline and Week 12

  4. Triglycerides

    Time frame: Baseline and Week 12

  5. Blood Pressure

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Effects of Varied Macronutrient Composition on Weight Loss in Obese Adolescents

Acronym: POWER

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2014
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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