Energy BalanceNCT02613065
The Role of Protein in Regulating Ad Libitum Energy Intake in Humans
A study testing Consumption of NOW Foods eggwhite protein shake and Consumption of NOW Foods maltodextrin shake in people with Energy Balance, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Balance
- What is being tested?
- Consumption of NOW Foods eggwhite protein shake and Consumption of NOW Foods maltodextrin shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2016
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥20, and ≤30 kg/m2
- Moderately active or sedentary (Physical Activity Level <2.0)
Who cannot join
- Any food allergy.
- Religious affiliations that include specific food guidelines.
- Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
- Weight loss or gain of >5% of body weight in the past 6 months for any reason except post-partum weight loss.
- Currently taking medication that suppresses or stimulates appetite or that affects body weight, including oral anti-diabetic medications.
- History of prior surgical procedure for weight control.
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- Anyone currently taking statins.
- Claustrophobia
- Current smoker or quit smoking less than 6 months prior.
- Any major disease, including:
- Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
- Active or chronic infections, including self-reported HIV positivity and active tuberculosis. -Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class >2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
- Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
- Active renal disease.
- Lung disease: chronic obstructive airway disease requiring use of oxygen.
- Diagnosed diabetes (type 1 or 2).
- Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
- A score on the Brief Symptom Inventory (BSI) (Derogatis \& Melisaratos, 1983) that exceeds the 90th percentile.
- History of or current eating disorders, or an Eating Attitudes Test (EAT-26) score >20.
- Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; another household member is a participant or staff member in the trial; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.
- Currently taking antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months.
- A recent or ongoing problem with drug abuse or addiction.
- Excessive alcohol intake, either acute or chronic, defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months; or 3) other evidence available to clinic staff.
- Pregnancy and childbearing: currently pregnant or less than 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the course of the trial; unwilling to take adequate contraceptive measures if potentially fertile.
- Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Energy Balance
- Being tested
- Consumption of NOW Foods eggwhite protein shake, Consumption of NOW Foods maltodextrin shake
- Keywords
- Ad libitum, Energy balance, Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of NOW Foods eggwhite protein shakeDietary supplement
Consumption of NOW Foods egg white protein shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.
Consumption of NOW Foods maltodextrin shakeDietary supplement
Consumption of NOW Foods maltodextrin shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.
| Study group | Role | What they receive |
|---|---|---|
| Eggwhite protein shake | Experimental | Participants drink a NOW Foods protein shake (~20% daily energy requirements) at the beginning of each of the three daily meals. Kcals/meal are dependent upon participant's baseline Resting Metabolic Rate value. Receives: Dietary Supplement: Consumption of NOW Foods eggwhite protein shake |
| Maltodextrin carbohydrate shake | Active comparator | Participants drink a NOW Foods carbohydrate shake (~20% daily energy requirements) at the beginning of each of the three daily meals. Kcals/meal are dependent upon participant's baseline Resting Metabolic Rate value. Receives: Dietary Supplement: Consumption of NOW Foods maltodextrin shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Balance measured as participant energy intake (food weight before and after meals) minus energy expenditure (accelerometer)
Feeding periods are separated by two weeks.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Energy BalanceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
- Responsible party
- Principal investigator, David Allison, Phd, University of Alabama at Birmingham
- Investigators
- David B Allison, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613065
- Sponsor's protocol ID
- F141121006
- Status last verified
- Aug 2016
- First submitted
- 17 Nov 2015
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gibson MJ, Dawson JA, Wijayatunga NN, Ironuma B, Chatindiara I, Ovalle F, Allison DB, Dhurandhar EJ. A randomized cross-over trial to determine the effect of a protein vs. carbohydrate preload on energy balance in ad libitum settings. Nutr J. 2019 Nov 9;18(1):69. doi: 10.1186/s12937-019-0497-4.
PubMed 31706311
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Protein in Regulating Ad Libitum Energy Intake in Humans
- ClinicalTrials.gov ID
- NCT02613065
- Acronym / sponsor ID
- F141121006
- Conditions
- Energy Balance
- Keywords
- Ad libitum, Energy balance, Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Nov 2015 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eggwhite protein shake | Experimental | Dietary Supplement: Consumption of NOW Foods eggwhite protein shakeParticipants drink a NOW Foods protein shake (~20% daily energy requirements) at the beginning of each of the three daily meals. Kcals/meal are dependent upon participant's baseline Resting Metabolic Rate value. |
| Maltodextrin carbohydrate shake | Active comparator | Dietary Supplement: Consumption of NOW Foods maltodextrin shakeParticipants drink a NOW Foods carbohydrate shake (~20% daily energy requirements) at the beginning of each of the three daily meals. Kcals/meal are dependent upon participant's baseline Resting Metabolic Rate value. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI ≥20, and ≤30 kg/m2
- Moderately active or sedentary (Physical Activity Level <2.0)
Key exclusion criteria (25 listed)
- Any food allergy.
- Religious affiliations that include specific food guidelines.
- Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
- Weight loss or gain of >5% of body weight in the past 6 months for any reason except post-partum weight loss.
- Currently taking medication that suppresses or stimulates appetite or that affects body weight, including oral anti-diabetic medications.
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 |
|---|---|---|
| Consumption of NOW Foods eggwhite protein shakeConsumption of NOW Foods egg white protein shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs. | Dietary supplement | Eggwhite protein shake |
| Consumption of NOW Foods maltodextrin shakeConsumption of NOW Foods maltodextrin shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs. | Dietary supplement | Maltodextrin carbohydrate shake |
Primary outcome
Energy Balance measured as participant energy intake (food weight before and after meals) minus energy expenditure (accelerometer)
Time frame: 10 days
Feeding periods are separated by two weeks.
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 22 Aug 2016.
- Derived from this study: PubMed 31706311Gibson MJ, Dawson JA, Wijayatunga NN, Ironuma B, Chatindiara I, Ovalle F, Allison DB, Dhurandhar EJ. A randomized cross-over trial to determine the effect of a protein vs. carbohydrate preload on energy balance in ad libitum settings. Nutr J. 2019 Nov 9;18(1):69. doi: 10.1186/s12937-019-0497-4.
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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.
David B Allison, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of NOW Foods eggwhite protein shake and Consumption of NOW Foods maltodextrin shake in people with Energy Balance, run by University of Alabama at Birmingham 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 2 inclusion and 25 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 22 Aug 2016. 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?
Energy Balance measured as participant energy intake (food weight before and after meals) minus energy expenditure (accelerometer) (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02613065, which also lists 1 linked publication.
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 22 Aug 2016.