Food IntakeQuaker ANCT01666561
The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.
A study testing Breakfast Test Cereal 1, Oat based, Breakfast Test Cereal 2, Oat-based and Ready-to-eat cereal in people with Food Intake and Satiety, run by Frank Greenway at 1 site in United States.
Trial summary
To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety over the 4 hour period following breakfast. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Intake, Satiety
- What is being tested?
- Breakfast Test Cereal 1, Oat based, Breakfast Test Cereal 2, Oat-based and Ready-to-eat cereal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jul 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older and are healthy.
- Taking no regular medications other than birth control or hormone replacement therapy.
- Are willing to use an effective method of birth control if you are capable of bearing children. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.
Who cannot join
- Are a woman who is pregnant or nursing a baby.
- Have gained or lost 8.8 pounds or more in the last 3 months.
- Have diabetes or a fasting blood sugar over 126 mg/dL.
- Have a score of 14 or greater on the restraint scale of the 3-factor eating questionnaire (a questionnaire which will be given to you by the study staff).
- Are allergic to oats, lactose-free milk, Honey Nut Cheerios or oatmeal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety over the 4 hour period following breakfast.
Read the detailed description
The subjects will be randomly assigned to one of these three breakfasts and then given a Visual analogue scales of hunger and satiety which will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on 2 other days separated by at least a week to repeat the breakfast test.
- Conditions
- Food Intake, Satiety
- Being tested
- Breakfast Test Cereal 1, Oat based, Breakfast Test Cereal 2, Oat-based, Ready-to-eat cereal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast Test Cereal 1, Oat basedOther
The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (a) one serving of oat based breakfast cereal 1.
Breakfast Test Cereal 2, Oat-basedOther
The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (b) an equicaloric amount of Oat based breakfast cereal 2.
Ready-to-eat cerealOther
The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (c) an equicaloric amount of the ready-to-eat cold cereal.
| Study group | Role | What they receive |
|---|---|---|
| Breakfast Test Cereal 1, Oat based | Experimental | Test cereal 1, Oat based breakfast cereal- you will be randomly presented with a breakfast consisting of either:
Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal. Receives: Other: Breakfast Test Cereal 1, Oat based; Other: Breakfast Test Cereal 2, Oat-based; Other: Ready-to-eat cereal |
| Breakfast Test Cereal 2, Oat-based | Experimental | Test Cereal 2, Oat-based breakfast cereal. You will be randomly presented with a breakfast consisting of either:
Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat oat brand cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal. Receives: Other: Breakfast Test Cereal 1, Oat based; Other: Breakfast Test Cereal 2, Oat-based; Other: Ready-to-eat cereal |
| Ready-to-eat cereal | Experimental | Ready-to-eat cereal, Oat based breakfast cereal- you will be randomly presented with a breakfast consisting of either:
one Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal. Receives: Other: Breakfast Test Cereal 1, Oat based; Other: Breakfast Test Cereal 2, Oat-based; Other: Ready-to-eat cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety Impact
Breakfast containing of oat-based breakfast cereal will cause people to feel more satiated compared to a breakfast containing of ready-to-eat oat-based breakfast cereal. Appetite and satiety will be measured with a Visual Analog Scale.
Measured: up to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food IntakeStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank Greenway
- Sponsor type
- University, hospital or other
- Collaborators
- PepsiCo Global R&D, Quaker Oats Company
- Responsible party
- Sponsor-investigator, Frank Greenway, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666561
- Sponsor's protocol ID
- PBRC 12029 (Period 1)
- Acronym
- Quaker A
- Status last verified
- Dec 2015
- First submitted
- 14 Aug 2012
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.
- ClinicalTrials.gov ID
- NCT01666561
- Acronym / sponsor ID
- Quaker A / PBRC 12029 (Period 1)
- Conditions
- Food Intake, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Frank GreenwayUniversity, hospital or other
- Collaborators
- PepsiCo Global R&D, Quaker Oats Company
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Aug 2012 (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.
To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety over the 4 hour period following breakfast.
Detailed description
The subjects will be randomly assigned to one of these three breakfasts and then given a Visual analogue scales of hunger and satiety which will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on 2 other days separated by at least a week to repeat the breakfast test.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breakfast Test Cereal 1, Oat based | Experimental | Other: Breakfast Test Cereal 1, Oat based, Other: Breakfast Test Cereal 2, Oat-based, Other: Ready-to-eat cerealTest cereal 1, Oat based breakfast cereal- you will be randomly presented with a breakfast consisting of either: Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal. |
| Breakfast Test Cereal 2, Oat-based | Experimental | Other: Breakfast Test Cereal 1, Oat based, Other: Breakfast Test Cereal 2, Oat-based, Other: Ready-to-eat cerealTest Cereal 2, Oat-based breakfast cereal. You will be randomly presented with a breakfast consisting of either: Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat oat brand cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal. |
| Ready-to-eat cereal | Experimental | Other: Breakfast Test Cereal 1, Oat based, Other: Breakfast Test Cereal 2, Oat-based, Other: Ready-to-eat cerealReady-to-eat cereal, Oat based breakfast cereal- you will be randomly presented with a breakfast consisting of either: one Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older and are healthy.
- Taking no regular medications other than birth control or hormone replacement therapy.
- Are willing to use an effective method of birth control if you are capable of bearing children. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.
Key exclusion criteria (5 listed)
- Are a woman who is pregnant or nursing a baby.
- Have gained or lost 8.8 pounds or more in the last 3 months.
- Have diabetes or a fasting blood sugar over 126 mg/dL.
- Have a score of 14 or greater on the restraint scale of the 3-factor eating questionnaire (a questionnaire which will be given to you by the study staff).
- Are allergic to oats, lactose-free milk, Honey Nut Cheerios or oatmeal.
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 |
|---|---|---|
| Breakfast Test Cereal 1, Oat basedThe study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (a) one serving of oat based breakfast cereal 1. | Other | Breakfast Test Cereal 1, Oat based, Breakfast Test Cereal 2, Oat-based, Ready-to-eat cereal |
| Breakfast Test Cereal 2, Oat-basedThe study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (b) an equicaloric amount of Oat based breakfast cereal 2. | Other | Breakfast Test Cereal 1, Oat based, Breakfast Test Cereal 2, Oat-based, Ready-to-eat cereal |
| Ready-to-eat cerealThe study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (c) an equicaloric amount of the ready-to-eat cold cereal. | Other | Breakfast Test Cereal 1, Oat based, Breakfast Test Cereal 2, Oat-based, Ready-to-eat cereal |
Primary outcome
Satiety Impact
Time frame: up to day 3
Breakfast containing of oat-based breakfast cereal will cause people to feel more satiated compared to a breakfast containing of ready-to-eat oat-based breakfast cereal. Appetite and satiety will be measured with a Visual Analog Scale.
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 18 Dec 2015.
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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 Breakfast Test Cereal 1, Oat based, Breakfast Test Cereal 2, Oat-based and Ready-to-eat cereal in people with Food Intake and Satiety, run by Frank Greenway 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 18 Dec 2015. 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?
Satiety Impact (time frame: up to day 3). 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 18 Dec 2015.