Subjective Appetite and SatietyPhase 4NCT01372683
Oat Breakfast Satiety Study
A Phase 4 study testing Dietary Intervention in people with Subjective Appetite and Satiety and Subjective Energy Levels, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjective Appetite and Satiety, Subjective Energy Levels
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 4
- 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
- Male or female
- 18 years of age or older
- Healthy
- Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children
Who cannot join
- Women who are pregnant or nursing
- Gain or loss of > 4kg in the last 3 months.
- Diabetes mellitus (fasting glucose >126 mg/dL)
- Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14
- Allergy to any of the foods used for the test breakfasts (oats or milk)
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
This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density.
Read the detailed description
This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density. Ninety-six healthy men and women 18 years of age or older will be enrolled into this study and divided into 2 groups of 48 each to investigate the satiety impact of two oat based breakfast cereals compared to the leading ready-to-eat (RTE) oat based breakfast cereal. Each subject will participate in two test sessions (1 test cereal vs the leading RTE cereal). Subjects will come to the Ingestive Behavior Laboratory between 8 and 10 am after having nothing to eat for 10 hours prior to the scheduled visit time and be given one of the three cereals. The second session will be scheduled at least 1 week after the first. Visual analogue scales of hunger, satiety and subjective energy will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on another day separated by at least a week to repeat the breakfast. Area under the curves of appetite and satiety will be compared with a mixed model.
- Being tested
- Dietary Intervention
- Keywords
- Appetite, Satiety, Subjective energy, Oats
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Comparison of oat based breakfast cereals
| Study group | Role | What they receive |
|---|---|---|
| Test cereal 1 | Experimental | Oat based breakfast cereal Receives: Other: Dietary Intervention |
| Test cereal 2 | Experimental | 2nd Oat based breakfast cereal Receives: Other: Dietary Intervention |
| Leading oat based RTE cereal | Experimental | 3rd oat based breakfast cereal Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of appetite and satiety
Measured: 4 hours
Secondary outcomes (1)
Area under the curve for subjective energy measures
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Appetite and SatietyStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Frank Greenway, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372683
- Sponsor's protocol ID
- PEP 1103
- Status last verified
- Dec 2011
- First submitted
- 10 Jun 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oat Based Breakfast Cereals on Satiety
- ClinicalTrials.gov ID
- NCT01372683
- Acronym / sponsor ID
- PEP 1103
- Keywords
- Appetite, Satiety, Subjective energy, Oats
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Collaborators
- Pennington Biomedical Research Center
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Jun 2011 (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 designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density.
Detailed description
This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density. Ninety-six healthy men and women 18 years of age or older will be enrolled into this study and divided into 2 groups of 48 each to investigate the satiety impact of two oat based breakfast cereals compared to the leading ready-to-eat (RTE) oat based breakfast cereal. Each subject will participate in two test sessions (1 test cereal vs the leading RTE cereal). Subjects will come to the Ingestive Behavior Laboratory between 8 and 10 am after having nothing to eat for 10 hours prior to the scheduled visit time and be given one of the three cereals. The second session will be scheduled at least 1 week after the first. Visual analogue scales of hunger, satiety and subjective energy will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on another day separated by at least a week to repeat the breakfast. Area under the curves of appetite and satiety will be compared with a mixed model.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test cereal 1 | Experimental | Other: Dietary InterventionOat based breakfast cereal |
| Test cereal 2 | Experimental | Other: Dietary Intervention2nd Oat based breakfast cereal |
| Leading oat based RTE cereal | Experimental | Other: Dietary Intervention3rd oat based breakfast cereal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female
- 18 years of age or older
- Healthy
- Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children
Key exclusion criteria (5 listed)
- Women who are pregnant or nursing
- Gain or loss of > 4kg in the last 3 months.
- Diabetes mellitus (fasting glucose >126 mg/dL)
- Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14
- Allergy to any of the foods used for the test breakfasts (oats or milk)
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 |
|---|---|---|
| Dietary InterventionComparison of oat based breakfast cereals | Other | Leading oat based RTE cereal, Test cereal 1, Test cereal 2 |
Primary outcome
Area under the curve (AUC) of appetite and satiety
Time frame: 4 hours
1 secondary outcome
Area under the curve for subjective energy measures
Time frame: 4 hours
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 20 Dec 2011.
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.
Frank Greenway, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dietary Intervention in people with Subjective Appetite and Satiety and Subjective Energy Levels, run by PepsiCo Global R&D 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 4 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 20 Dec 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Area under the curve (AUC) of appetite and satiety (time frame: 4 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 20 Dec 2011; AzTrials last refreshed its copy on 27 Oct 2026.