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Oat Breakfast Satiety Study

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ClinicalTrials.gov Identifier: NCT01372683
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : December 20, 2011
Sponsor:
Collaborator:
Pennington Biomedical Research Center
Information provided by (Responsible Party):
PepsiCo Global R&D

Brief 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.

Condition or disease Intervention/treatment Phase
Subjective Appetite and Satiety Subjective Energy Levels Other: Dietary Intervention Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Oat Based Breakfast Cereals on Satiety
Study Start Date : May 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Test cereal 1
Oat based breakfast cereal
Other: Dietary Intervention
Comparison of oat based breakfast cereals
Experimental: Test cereal 2
2nd Oat based breakfast cereal
Other: Dietary Intervention
Comparison of oat based breakfast cereals
Experimental: Leading oat based RTE cereal
3rd oat based breakfast cereal
Other: Dietary Intervention
Comparison of oat based breakfast cereals



Primary Outcome Measures :
  1. Area under the curve (AUC) of appetite and satiety [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. Area under the curve for subjective energy measures [ Time Frame: 4 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372683


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
PepsiCo Global R&D
Pennington Biomedical Research Center
Investigators
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center

Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT01372683     History of Changes
Other Study ID Numbers: PEP 1103
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by PepsiCo Global R&D:
Appetite
Satiety
Subjective energy
Oats