HealthyNCT04740112
Beta-glucan, Product Claims and Satiety
A study testing Foods with beta-glucan from oats and barley in people with Healthy, run by General Mills at 1 site in United States.
Trial summary
This is a digital clinical trial to investigate satiety and consumer preference in responses to three test breakfast bars with varying level of dietary fiber, beta-glucan, and product packages (with or without product claims) in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Foods with beta-glucan from oats and barley
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 30 Jun 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults 18-70 years.
- Habitual snack bar consumers (consume bars at least 3 times a week).
- Body mass index 20-29.9 kg/m² (based on self-reported weight and height).
- Understand the study procedures.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to follow study procedures on test days.
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- Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day.
- Willing to provide informed consent to participate in the study.
- Willing to maintain confidentiality of the study and test products.
Who cannot join
- Pregnant or lactating women, or women who are planning to become pregnant during the study
- Known food allergies, sensitivity, or intolerance to any food or food ingredients
- Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
- Taking medications that affect appetite, metabolism, or blood pressure
- Taking supplements with dietary fiber
- Presence of acute diseases or infection
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- Presence or history of chronic diseases
- Diagnosed with eating disorders
- Restraint eaters
- Lost or gained 5 pounds or more in the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
No physical visit to a research facility is required.
Minneapolis, Minnesota, 55427
About this study
Official title: Effects of Beta-glucan and Product Claims for Breakfast Bars on Appetite Response and Consumer Preference: a Randomized Controlled Trial
This is a digital clinical trial to investigate satiety and consumer preference in responses to three test breakfast bars with varying level of dietary fiber, beta-glucan, and product packages (with or without product claims) in healthy adults.
- Conditions
- Healthy
- Being tested
- Foods with beta-glucan from oats and barley
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foods with beta-glucan from oats and barleyOther
Also called Food
Breakfast bars made with varying levels of total dietary fiber and beta-glucan, with or without claims on package image
| Study group | Role | What they receive |
|---|---|---|
| Control breakfast bar with low dietary fiber without product claims | Placebo comparator | Not described Receives: Other: Foods with beta-glucan from oats and barley |
| Test breakfast bar with high dietary fiber without product claims | Experimental | Not described Receives: Other: Foods with beta-glucan from oats and barley |
| Test breakfast bar with high dietary fiber with product claims | Experimental | Not described Receives: Other: Foods with beta-glucan from oats and barley |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunger
Hunger as measured by visual analog scales in mm using appetite questionnaires
Measured: 30 minutes after consumption
Hunger
Hunger as measured by visual analog scales in mm using appetite questionnaires
Measured: 60 minutes after consumption
Hunger
Hunger as measured by visual analog scales in mm using appetite questionnaires
Measured: 90 minutes after consumption
Hunger
Hunger as measured by visual analog scales in mm using appetite questionnaires
Measured: 120 minutes after consumption
Hunger
Hunger as measured by visual analog scales in mm using appetite questionnaires
Measured: 180 minutes after consumption
Fullness
Fullness as measured by visual analog scales in mm using appetite questionnaires
Measured: 30 minutes after consumption
Fullness
Fullness as measured by visual analog scales in mm using appetite questionnaires
Measured: 60 minutes after consumption
Fullness
Fullness as measured by visual analog scales in mm using appetite questionnaires
Measured: 90 minutes after consumption
Fullness
Fullness as measured by visual analog scales in mm using appetite questionnaires
Measured: 120 minutes after consumption
Fullness
Fullness as measured by visual analog scales in mm using appetite questionnaires
Measured: 180 minutes after consumption
Desire to eat
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Measured: 30 minutes after test meal consumption
Desire to eat
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Measured: 60 minutes after test meal consumption
Desire to eat
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Measured: 90 minutes after test meal consumption
Desire to eat
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Measured: 120 minutes after test meal consumption
Desire to eat
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Measured: 180 minutes after test meal consumption
Prospective consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
Measured: 30 minutes after test meal consumption
Prospective consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
Measured: 60 minutes after test meal consumption
Prospective consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
Measured: 90 minutes after test meal consumption
Prospective consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
Measured: 120 minutes after test meal consumption
Prospective consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
Measured: 180 minutes after test meal consumption
Secondary outcomes (5)
Flavor rating
Subjective ratings on liking of the product flavor using Likert scales
Measured: 30 minutes after test meal consumption
Sweetness rating
Subjective ratings on sweetness of the product using Likert scales
Measured: 30 minutes after test meal consumption
Texture rating
Subjective ratings on liking of the product texture using Likert scales
Measured: 30 minutes after test meal consumption
Overall product liking
Subjective ratings on overall liking of the product using Likert scales
Measured: 30 minutes after test meal consumption
Purchase intent
Likelihood of buying the product using Likert scales
Measured: 180 minutes after test meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start28 Jan 2021
- Primary completion28 Feb 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Mills
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740112
- Sponsor's protocol ID
- 2021/01/7
- Status last verified
- Mar 2024
- First submitted
- 27 Jan 2021
- Last updated
- 6 Mar 2024
- Results posted
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Beta-glucan and Product Claims for Breakfast Bars on Appetite Response and Consumer Preference: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04740112
- Acronym / sponsor ID
- 2021/01/7
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- General MillsIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Feb 2021 (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 is a digital clinical trial to investigate satiety and consumer preference in responses to three test breakfast bars with varying level of dietary fiber, beta-glucan, and product packages (with or without product claims) in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control breakfast bar with low dietary fiber without product claims | Placebo comparator | Other: Foods with beta-glucan from oats and barley |
| Test breakfast bar with high dietary fiber without product claims | Experimental | Other: Foods with beta-glucan from oats and barley |
| Test breakfast bar with high dietary fiber with product claims | Experimental | Other: Foods with beta-glucan from oats and barley |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy adults 18-70 years.
- Habitual snack bar consumers (consume bars at least 3 times a week).
- Body mass index 20-29.9 kg/m² (based on self-reported weight and height).
- Understand the study procedures.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
Key exclusion criteria (10 listed)
- Pregnant or lactating women, or women who are planning to become pregnant during the study
- Known food allergies, sensitivity, or intolerance to any food or food ingredients
- Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
- Taking medications that affect appetite, metabolism, or blood pressure
- Taking supplements with dietary fiber
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 |
|---|---|---|
| Foods with beta-glucan from oats and barleyAlso: FoodBreakfast bars made with varying levels of total dietary fiber and beta-glucan, with or without claims on package image | Other | Control breakfast bar with low dietary fiber without product claims, Test breakfast bar with high dietary fiber with product claims, Test breakfast bar with high dietary fiber without product claims |
Primary outcome
Hunger
Time frame: 30 minutes after consumption
Hunger as measured by visual analog scales in mm using appetite questionnaires
Hunger
Time frame: 60 minutes after consumption
Hunger as measured by visual analog scales in mm using appetite questionnaires
Hunger
Time frame: 90 minutes after consumption
Hunger as measured by visual analog scales in mm using appetite questionnaires
Hunger
Time frame: 120 minutes after consumption
Hunger as measured by visual analog scales in mm using appetite questionnaires
Hunger
Time frame: 180 minutes after consumption
Hunger as measured by visual analog scales in mm using appetite questionnaires
Fullness
Time frame: 30 minutes after consumption
Fullness as measured by visual analog scales in mm using appetite questionnaires
Fullness
Time frame: 60 minutes after consumption
Fullness as measured by visual analog scales in mm using appetite questionnaires
Fullness
Time frame: 90 minutes after consumption
Fullness as measured by visual analog scales in mm using appetite questionnaires
Fullness
Time frame: 120 minutes after consumption
Fullness as measured by visual analog scales in mm using appetite questionnaires
Fullness
Time frame: 180 minutes after consumption
Fullness as measured by visual analog scales in mm using appetite questionnaires
Desire to eat
Time frame: 30 minutes after test meal consumption
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Desire to eat
Time frame: 60 minutes after test meal consumption
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Desire to eat
Time frame: 90 minutes after test meal consumption
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Desire to eat
Time frame: 120 minutes after test meal consumption
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Desire to eat
Time frame: 180 minutes after test meal consumption
Desire to eat as measured by visual analog scales in mm using appetite questionnaires
Prospective consumption
Time frame: 30 minutes after test meal consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
Prospective consumption
Time frame: 60 minutes after test meal consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
Prospective consumption
Time frame: 90 minutes after test meal consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
Prospective consumption
Time frame: 120 minutes after test meal consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
Prospective consumption
Time frame: 180 minutes after test meal consumption
Prospective consumption as measured by visual analog scales in mm using appetite questionnaires
5 secondary outcomes
Flavor rating
Time frame: 30 minutes after test meal consumption
Sweetness rating
Time frame: 30 minutes after test meal consumption
Texture rating
Time frame: 30 minutes after test meal consumption
Overall product liking
Time frame: 30 minutes after test meal consumption
Purchase intent
Time frame: 180 minutes after test meal consumption
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 6 Mar 2024.
- 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 Foods with beta-glucan from oats and barley in people with Healthy, run by General Mills 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 9 inclusion and 10 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 6 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Hunger (time frame: 30 minutes after consumption). The study lists 20 primary outcomes in all. 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 6 Mar 2024.