NCT01372683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 20, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

June 10, 2011

Last Update Submit

December 19, 2011

Conditions

Subjective Appetite and SatietySubjective Energy Levels

Keywords

AppetiteSatietySubjective energyOats

Outcome Measures

Primary Outcomes (1)

  • Area under the curve (AUC) of appetite and satiety

    4 hours

Secondary Outcomes (1)

  • Area under the curve for subjective energy measures

    4 hours

Study Arms (3)

Test cereal 1

EXPERIMENTAL

Oat based breakfast cereal

Other: Dietary Intervention

Test cereal 2

EXPERIMENTAL

2nd Oat based breakfast cereal

Other: Dietary Intervention

Leading oat based RTE cereal

EXPERIMENTAL

3rd oat based breakfast cereal

Other: Dietary Intervention

Interventions

Dietary InterventionOTHER

Comparison of oat based breakfast cereals

Leading oat based RTE cerealTest cereal 1Test cereal 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • years of age or older
  • Healthy
  • Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Frank Greenway, MD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 14, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

December 20, 2011

Record last verified: 2011-12

Locations

US(1)