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NCT02613065 · ClinicalTrials.gov registry record · NA
The Role of Protein in Regulating Ad Libitum Energy Intake in Humans
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT02613065: Completed NA study, sponsored by University of Alabama at Birmingham.
NCT02613065 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02613065, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this project is to determine if protein is less likely to create positive energy balance when added to the diet compared to carbohydrate. To do this, the investigators will take detailed measurements of participant's baseline metabolic rate to understand their energy requirements. Then, the investigators will feed participants all their meals for two weeks, Monday-Friday, and measure their food intake. During one of the week-long feeding periods, participants will consume a shake made of egg protein that is \~20% of their energy requirements. During the other week, participants will consume a shake made of carbohydrate that is \~20% of their energy requirements. Participants will drink the assigned shake at the beginning of each of their daily three meals, and then they will be offered a 'regular' meal of unlimited quantity. Participants will not know that the investigators are measuring the food consumed after drinking the shake. Participants will drink the protein shake for the first week and carb-based shake for the second week, and vice versa-- depending on the randomization order. To account for energy expenditure, participants will wear an activity monitor, an accelerometer. Energy balance, measured as participant energy intake minus energy expenditure, will be our main outcome for each treatment. However, because participants may change their behavior if made aware of the true research question, the investigators will tell participants that the purpose of the study is to see how low fiber and high fiber shakes affect mood. The hypothesis is that during the week when participants consume the protein shake, they will remain in energy balance, but during the week of carbohydrate shake consumption, participants will have positive energy balance.
Primary Outcome
Feeding periods are separated by two weeks.
Interventions
- DIETARY_SUPPLEMENT Consumption of NOW Foods eggwhite protein shake
- DIETARY_SUPPLEMENT Consumption of NOW Foods maltodextrin shake
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-06 |
| Phase | NA |
What the finished NCT02613065 record still lists
NCT02613065 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Consumption of NOW Foods eggwhite protein shake is the first listed.
NCT02613065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02613065 about?
NCT02613065 is a clinical study titled "The Role of Protein in Regulating Ad Libitum Energy Intake in Humans". The purpose of this project is to determine if protein is less likely to create positive energy balance when added to the diet compared to carbohydrate. To do this, the investigators will take detailed measurements of participant's baseline metabolic rate to understand their energy requirements. The...
What is the current status of trial NCT02613065?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2015-05. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02613065?
The interventions under investigation include: Consumption of NOW Foods eggwhite protein shake (DIETARY_SUPPLEMENT), Consumption of NOW Foods maltodextrin shake (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02613065?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02613065's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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