Pediatric ObesityPOWERNCT02079831
PrOtein and WEight Loss in teenageRs
A study testing Energy Restriction, Higher protein and Lower Protein in people with Pediatric Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Energy Restriction, Higher protein and Lower Protein
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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).
- Conditions
- Pediatric Obesity
- Being tested
- Energy Restriction, Higher protein, Lower Protein
- Keywords
- Adolescent obesity, childhood obesity, anthropometry, body weights and measures
- Medical subject headings
- Pediatric Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy RestrictionBehavioural
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 proteinBehavioural
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 ProteinBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Higher protein and energy restriction | Experimental | Participants in this arm will consume 30% of energy as protein with 25% energy restriction. Receives: Behavioral: Energy Restriction; Behavioral: Higher protein |
| Lower protein and energy restriction | Experimental | Participants in this arm will consume 15% of energy as protein with 25% energy restriction. Receives: Behavioral: Energy Restriction; Behavioral: Lower Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Z-Score
Measured: up to Week 12
Secondary outcomes (2)
Subjective Ratings of Appetite
Measured: 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
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Apolzan, Pennington Biomedical Research Center
- Investigators
- John W Apolzan, PhD, Principal investigator, Pennington Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079831
- Sponsor's protocol ID
- PBRC 2014-014
- Acronym
- POWER
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2014
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Varied Macronutrient Composition on Weight Loss in Obese Adolescents
- ClinicalTrials.gov ID
- NCT02079831
- Acronym / sponsor ID
- POWER / PBRC 2014-014
- Conditions
- Pediatric Obesity
- Keywords
- Adolescent obesity, childhood obesity, anthropometry, body weights and measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher protein and energy restriction | Experimental | Behavioral: Energy Restriction, Behavioral: Higher proteinParticipants in this arm will consume 30% of energy as protein with 25% energy restriction. |
| Lower protein and energy restriction | Experimental | Behavioral: Energy Restriction, Behavioral: Lower ProteinParticipants in this arm will consume 15% of energy as protein with 25% energy restriction. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy RestrictionParticipants 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. | Behavioural | Higher protein and energy restriction, Lower protein and energy restriction |
| Higher proteinThe higher protein group will be instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively. | Behavioural | Higher protein and energy restriction |
| Lower ProteinThe lower protein group will be instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively. | Behavioural | Lower protein and energy restriction |
Primary outcome
BMI Z-Score
Time frame: up to Week 12
2 secondary outcomes
Subjective Ratings of Appetite
Time frame: Baseline and Week 12
Hexosamine Biosynthetic Pathway
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Apolzan, PhD principal investigator
Pennington Biomedical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Restriction, Higher protein and Lower Protein in people with Pediatric Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI Z-Score (time frame: up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.