The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake

This study has been completed.
Sponsor:
Collaborators:
PepsiCo Global R&D
Quaker Oats
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01666574
First received: August 14, 2012
Last updated: June 6, 2014
Last verified: June 2014

August 14, 2012
June 6, 2014
August 2012
June 2013   (final data collection date for primary outcome measure)
Satiety Impact [ Time Frame: Baseline to 2 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01666574 on ClinicalTrials.gov Archive Site
Impact on food intake at lunch [ Time Frame: Baseline to 2 days ] [ Designated as safety issue: No ]

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

Same as current
Not Provided
Not Provided
 
The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Food Intake
  • Satiety
  • Other: Test cereal 1, Oat-based
    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.
  • Other: Test Cereal 2, Oat based
    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.
  • Experimental: Test cereal 1, Oat-based
    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.
    Interventions:
    • Other: Test cereal 1, Oat-based
    • Other: Test Cereal 2, Oat based
  • Experimental: Test Cereal 2, Oat based
    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.
    Interventions:
    • Other: Test cereal 1, Oat-based
    • Other: Test Cereal 2, Oat based
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
July 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01666574
PBRC12029 (Period 2)
No
Frank Greenway, Pennington Biomedical Research Center
Pennington Biomedical Research Center
  • PepsiCo Global R&D
  • Quaker Oats
Not Provided
Pennington Biomedical Research Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP