AgingNCT03399812
Breakfast and Metabolism in Men
A study testing Animal protein and Plant protein in people with Aging, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial summary
This study will determine the short-term postprandial effects of protein source at breakfast on energy metabolism, markers of metabolic health, appetite, and food intake and young and older men. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Animal protein and Plant protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 30 Jun 2018
- 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 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- No medication
- Athlete (elite or professional)
Who cannot join
- Diet-related conditions
- Food allergies
- Does not regularly consume protein supplements
- Claustrophobic
- Underweight
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72704
About this study
Official title: The Effect of Breakfast on Energy Metabolism, Appetite, and Food Intake in Men
This study will determine the short-term postprandial effects of protein source at breakfast on energy metabolism, markers of metabolic health, appetite, and food intake and young and older men.
- Conditions
- Aging
- Being tested
- Animal protein, Plant protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal proteinDietary supplement
The animal protein intervention is a smoothie containing 40 grams of whey protein isolate.
Plant proteinDietary supplement
The animal protein intervention is a smoothie containing 40 grams of pea protein isolate.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein isolate | Experimental | Not described Receives: Dietary Supplement: Animal protein |
| Pea protein isolate | Active comparator | Not described Receives: Dietary Supplement: Plant protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Energy expended per minute will be measured using indirect calorimetry.
Measured: Time frame is every 30 minutes for four hours following intervention.
Appetite
Appetite will be assessed using a traditional 100-mm visual analog scale (VAS) (3) with opposing anchors (e.g., "extremely hungry" or "not hungry at all") at time points 15, 30, 60, 90, 120, 180 and 240 min. Questions consisted of: "how hungry do you feel at this moment", "how full do you feel at this moment", "how strong is your desire to eat this moment" and "how much food do you think you can eat at this moment." Participants were asked to place an "X" on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point." Participants were asked to place an "X" on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point. The averages for each time point are taken to represent the feeling of appetitive at a particular time point.
Measured: Time frame is every 30 minutes for four hours following intervention.
Secondary outcomes (1)
24-hour food intake
Food intake following the intervention will be recorded using food records.
Measured: Food intake will be recorded for one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start15 Dec 2017
- Primary completion30 Apr 2018
- Study completion30 Jun 2018
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 AgingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Baum, University of Arkansas, Fayetteville
- Investigators
- Jamie Baum, Principal investigator, University of Arkansas, Fayetteville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399812
- Sponsor's protocol ID
- 1708038914
- Status last verified
- Jul 2018
- First submitted
- 8 Jan 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hawley AL, Gbur E, Tacinelli AM, Walker S, Murphy A, Burgess R, Baum JI. The Short-Term Effect of Whey Compared with Pea Protein on Appetite, Food Intake, and Energy Expenditure in Young and Older Men. Curr Dev Nutr. 2020 Jan 22;4(2):nzaa009. doi: 10.1093/cdn/nzaa009. eCollection 2020 Feb.
PubMed 32072131
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breakfast on Energy Metabolism, Appetite, and Food Intake in Men
- ClinicalTrials.gov ID
- NCT03399812
- Acronym / sponsor ID
- 1708038914
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Jan 2018 (actual)
- 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.
This study will determine the short-term postprandial effects of protein source at breakfast on energy metabolism, markers of metabolic health, appetite, and food intake and young and older men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey protein isolate | Experimental | Dietary Supplement: Animal protein |
| Pea protein isolate | Active comparator | Dietary Supplement: Plant protein |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- No medication
- Athlete (elite or professional)
Key exclusion criteria (5 listed)
- Diet-related conditions
- Food allergies
- Does not regularly consume protein supplements
- Claustrophobic
- Underweight
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 |
|---|---|---|
| Animal proteinThe animal protein intervention is a smoothie containing 40 grams of whey protein isolate. | Dietary supplement | Whey protein isolate |
| Plant proteinThe animal protein intervention is a smoothie containing 40 grams of pea protein isolate. | Dietary supplement | Pea protein isolate |
Primary outcome
Energy expenditure
Time frame: Time frame is every 30 minutes for four hours following intervention.
Energy expended per minute will be measured using indirect calorimetry.
Appetite
Time frame: Time frame is every 30 minutes for four hours following intervention.
Appetite will be assessed using a traditional 100-mm visual analog scale (VAS) (3) with opposing anchors (e.g., "extremely hungry" or "not hungry at all") at time points 15, 30, 60, 90, 120, 180 and 240 min. Questions consisted of: "how hungry do you feel at this moment", "how full do you feel at this moment", "how strong is your desire to eat this moment" and "how much food do you think you can eat at this moment." Participants were asked to place an "X" on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point." Participants were asked to place an "X" on the 100-mm VAS in the place that pertained to their perceived appetite feelings at each time point. The averages for each time point are taken to represent the feeling of appetitive at a particular time point.
1 secondary outcome
24-hour food intake
Time frame: Food intake will be recorded for one day.
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 17 Jul 2018.
- Derived from this study: PubMed 32072131Hawley AL, Gbur E, Tacinelli AM, Walker S, Murphy A, Burgess R, Baum JI. The Short-Term Effect of Whey Compared with Pea Protein on Appetite, Food Intake, and Energy Expenditure in Young and Older Men. Curr Dev Nutr. 2020 Jan 22;4(2):nzaa009. doi: 10.1093/cdn/nzaa009. eCollection 2020 Feb.
- Individual participant dataSharing planned: No
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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.
Jamie Baum principal investigator
University of Arkansas, Fayetteville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal protein and Plant protein in people with Aging, run by University of Arkansas, Fayetteville 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 3 inclusion and 5 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 17 Jul 2018. 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 expenditure (time frame: Time frame is every 30 minutes for four hours following intervention.). The study lists 2 primary outcomes in all. 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 NCT03399812, 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 17 Jul 2018.