ObesityNCT03083145
Protein Source, Nutrition Messaging, and Food Intake
A study testing Whey Protein Beverage, Pea Protein Beverage and Snack Tray Choices in people with Obesity, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial summary
The objective of this study is to determine how the protein source and the physical form of food consumed at breakfast impact food intake. Research will be conducted by assessing feelings of hunger, food preference and blood glucose in healthy adults following the ingestion protein-based (animal versus plant) drinks… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Whey Protein Beverage, Pea Protein Beverage and Snack Tray Choices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 1 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, no known health conditions
Who cannot join
- Taking medication, excluding hormonal birth control
- Food allergies
- Food intolerances
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72704
About this study
Official title: Evaluating How Breakfast Protein Source Affects Satiety, Glucose and Food Preference
The objective of this study is to determine how the protein source and the physical form of food consumed at breakfast impact food intake. Research will be conducted by assessing feelings of hunger, food preference and blood glucose in healthy adults following the ingestion protein-based (animal versus plant) drinks similar calorie and protein content.
- Conditions
- Obesity
- Being tested
- Whey Protein Beverage, Pea Protein Beverage, Snack Tray Choices
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein BeverageDietary supplement
Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.
Pea Protein BeverageDietary supplement
Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.
Snack Tray ChoicesBehavioural
Items were selected from a snack tray filled with healthy and unhealthy snacks in order to determine if educational messaging influenced snack choices. Shack choices wre recorded on a check list by a third party observer.
| Study group | Role | What they receive |
|---|---|---|
| Educational Messaging | Active comparator | Whey protein beverage and pea protein beverages administered in a randomized order with a one- to two-week washout period between beverages. Receives: Dietary Supplement: Whey Protein Beverage; Dietary Supplement: Pea Protein Beverage; Behavioral: Snack Tray Choices |
| No Messaging | Active comparator | Whey protein beverage and pea protein beverages administered in a randomized order with a one- to two-week washout period between beverages. Receives: Dietary Supplement: Whey Protein Beverage; Dietary Supplement: Pea Protein Beverage; Behavioral: Snack Tray Choices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite assessment
Appetite was assessed using visual analog scales
Measured: 2 hours
Secondary outcomes (1)
Snack intake using checklist
Snacks were provided after 2 hours and type and quantity of snacks consumed were monitored and recorded on a checklist by a member of the research team. At the end of the snacking period, uneaten portions of snacks were weighed and recorded.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Feb 2016
- Primary completion15 May 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083145
- Sponsor's protocol ID
- 15-05-753
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating How Breakfast Protein Source Affects Satiety, Glucose and Food Preference
- ClinicalTrials.gov ID
- NCT03083145
- Acronym / sponsor ID
- 15-05-753
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 17 Mar 2017 (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.
The objective of this study is to determine how the protein source and the physical form of food consumed at breakfast impact food intake. Research will be conducted by assessing feelings of hunger, food preference and blood glucose in healthy adults following the ingestion protein-based (animal versus plant) drinks similar calorie and protein content.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Messaging | Active comparator | Dietary Supplement: Whey Protein Beverage, Dietary Supplement: Pea Protein Beverage, Behavioral: Snack Tray ChoicesWhey protein beverage and pea protein beverages administered in a randomized order with a one- to two-week washout period between beverages. |
| No Messaging | Active comparator | Dietary Supplement: Whey Protein Beverage, Dietary Supplement: Pea Protein Beverage, Behavioral: Snack Tray ChoicesWhey protein beverage and pea protein beverages administered in a randomized order with a one- to two-week washout period between beverages. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, no known health conditions
Key exclusion criteria (3 listed)
- Taking medication, excluding hormonal birth control
- Food allergies
- Food intolerances
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 |
|---|---|---|
| Whey Protein BeverageBeverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray. | Dietary supplement | Educational Messaging, No Messaging |
| Pea Protein BeverageBeverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray. | Dietary supplement | Educational Messaging, No Messaging |
| Snack Tray ChoicesItems were selected from a snack tray filled with healthy and unhealthy snacks in order to determine if educational messaging influenced snack choices. Shack choices wre recorded on a check list by a third party observer. | Behavioural | Educational Messaging, No Messaging |
Primary outcome
Appetite assessment
Time frame: 2 hours
Appetite was assessed using visual analog scales
1 secondary outcome
Snack intake using checklist
Time frame: 1 hour
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 Mar 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Beverage, Pea Protein Beverage and Snack Tray Choices in people with Obesity, 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 1 inclusion and 3 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 Mar 2017. 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?
Appetite assessment (time frame: 2 hours). 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 17 Mar 2017.