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Clinical Trials/NCT02079831
NCT02079831
Completed
Not Applicable

Effects of Varied Macronutrient Composition on Weight Loss in Obese Adolescents

Pennington Biomedical Research Center1 site in 1 country32 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
Pennington Biomedical Research Center
Enrollment
32
Locations
1
Primary Endpoint
BMI Z-Score
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

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).

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Apolzan

Assistant Professor

Pennington Biomedical Research Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

BMI Z-Score

Time Frame: up to Week 12

Secondary Outcomes

  • Subjective Ratings of Appetite(Baseline and Week 12)
  • Hexosamine Biosynthetic Pathway(Baseline and Week 12)

Study Sites (1)

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