PrOtein and WEight Loss in teenageRs
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 10/14/2017 |
| Start Date: | March 2014 |
| End Date: | July 2015 |
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.
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.
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).
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).
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.
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