Food IntakeNCT01666574
The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake
A study testing Test cereal 1, Oat-based and Test Cereal 2, Oat based in people with Food Intake and Satiety, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study is to determine if two breakfasts of equivalent calories, an oat based breakfast cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also determine if the two calorically equivalent oat-based breakfast cereals give different caloric intakes at a lunch meal that participants… 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?
- Test cereal 1, Oat-based and Test Cereal 2, Oat based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 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
Official title: The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.
This study is to determine if two breakfasts of equivalent calories, an oat based breakfast cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also determine if the two calorically equivalent oat-based breakfast cereals give different caloric intakes at a lunch meal that participants will eat to their satisfaction.
Read the detailed description
The Second trial (Period 2): An additional 48 healthy men and women 18 years of age or older will be enrolled to investigate the satiety and food intake at lunch after a breakfast consisting of one of two randomly assigned oat-based cereals and milk breakfast. Visual analogue scales of hunger and satiety will be completed before breakfast and at, 30, 60, 120, 180, and 240 minutes following consumption. Subjects will be asked to eat Lunch until satisfied. The subjects will have the two breakfasts in a balanced and random order and the two meal tests will be separated by at least a week.
- Conditions
- Food Intake, Satiety
- Being tested
- Test cereal 1, Oat-based, Test Cereal 2, Oat based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test cereal 1, Oat-basedOther
The study design is a lunch that will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
Test Cereal 2, Oat basedOther
The study design is a two visit trial with each subject randomly receiving one of the cereals at each visit separated by at least a week. A lunch will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
| Study group | Role | What they receive |
|---|---|---|
| Test cereal 1, Oat-based | Experimental | The purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based cereal will cause people to eat less at lunch. Receives: Other: Test cereal 1, Oat-based; Other: Test Cereal 2, Oat based |
| Test Cereal 2, Oat based | Experimental | The purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based ready-to-eat cereal will cause people to eat less at lunch. Receives: Other: Test cereal 1, Oat-based; Other: Test Cereal 2, Oat based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety Impact
Breakfast containing 250 kcal of Oat-based breakfast cereal will cause people to eat less at lunch compared to a breakfast containing 250 kcal of the ready-to-eat oat-based breakfast cereal. Area under the curve (AUC) of appetite and satiety.
Measured: Baseline to 2 days
Secondary outcomes (1)
Impact on food intake at lunch
You will fill out a visual analog scales at 30, 60, 120, 180, and 240 minutes following the start of the breakfast meal each day.
Four hours after the start of breakfast, you will be presented with a lunch and will be asked to eat to your satisfaction over 20 minutes. You will be asked how you are feeling periodically throughout the test. Area under the curve for subjective energy measures
Measured: Baseline to 2 days
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 completionJun 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- PepsiCo Global R&D, Quaker Oats Company
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666574
- Sponsor's protocol ID
- PBRC 12029 (Period 2)
- 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
- NCT01666574
- Acronym / sponsor ID
- PBRC 12029 (Period 2)
- Conditions
- Food Intake, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- PepsiCo Global R&D, Quaker Oats Company
- Study start
- Aug 2012
- Primary completion
- Jun 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.
This study is to determine if two breakfasts of equivalent calories, an oat based breakfast cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also determine if the two calorically equivalent oat-based breakfast cereals give different caloric intakes at a lunch meal that participants will eat to their satisfaction.
Detailed description
The Second trial (Period 2): An additional 48 healthy men and women 18 years of age or older will be enrolled to investigate the satiety and food intake at lunch after a breakfast consisting of one of two randomly assigned oat-based cereals and milk breakfast. Visual analogue scales of hunger and satiety will be completed before breakfast and at, 30, 60, 120, 180, and 240 minutes following consumption. Subjects will be asked to eat Lunch until satisfied. The subjects will have the two breakfasts in a balanced and random order and the two meal tests will be separated by at least a week.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test cereal 1, Oat-based | Experimental | Other: Test cereal 1, Oat-based, Other: Test Cereal 2, Oat basedThe purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based cereal will cause people to eat less at lunch. |
| Test Cereal 2, Oat based | Experimental | Other: Test cereal 1, Oat-based, Other: Test Cereal 2, Oat basedThe purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based ready-to-eat cereal will cause people to eat less at lunch. |
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 |
|---|---|---|
| Test cereal 1, Oat-basedThe study design is a lunch that will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption. | Other | Test Cereal 2, Oat based, Test cereal 1, Oat-based |
| Test Cereal 2, Oat basedThe study design is a two visit trial with each subject randomly receiving one of the cereals at each visit separated by at least a week. A lunch will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption. | Other | Test Cereal 2, Oat based, Test cereal 1, Oat-based |
Primary outcome
Satiety Impact
Time frame: Baseline to 2 days
Breakfast containing 250 kcal of Oat-based breakfast cereal will cause people to eat less at lunch compared to a breakfast containing 250 kcal of the ready-to-eat oat-based breakfast cereal. Area under the curve (AUC) of appetite and satiety.
1 secondary outcome
Impact on food intake at lunch
Time frame: Baseline to 2 days
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 Test cereal 1, Oat-based and Test Cereal 2, Oat based in people with Food Intake and Satiety, run by Pennington Biomedical Research Center 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: Baseline to 2 days). 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.