The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.
Quaker A
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedDecember 18, 2015
December 1, 2015
11 months
August 14, 2012
December 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to day 3
Study Arms (3)
Breakfast Test Cereal 1, Oat based
EXPERIMENTALTest 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
EXPERIMENTALTest 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
EXPERIMENTALReady-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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Frank Greenwaylead
- PepsiCo Global R&Dcollaborator
- Quaker Oats Companycollaborator
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 16, 2012
Study Start
August 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
December 18, 2015
Record last verified: 2015-12