- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01042418
Appetite Profile After Intake of Rye Breakfast Meal
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of the present study was to investigate if rye grain structure influence perceived appetite. A comparison of whole rye kernels and milled rye kernels were done in two study parts. In the first part the rye was served as porridge breakfasts and in the second one milled and whole kernels were included into bread breakfasts. In order to observe potential effects that would arise when the remains of the meal reaches the colon, the period of measurement was set to 8 h after intake of iso-caloric rye bread and rye porridge breakfasts.
A randomized, crossover design was used to compare the effects of iso-caloric breakfast meals on subjective appetite during 8 h after consumption.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 20 and 60 years;
- body mass index (BMI) 18-27 kg/m2;
- habit of consuming breakfast, lunch and dinner every day
- willingness to comply with the study procedures
Exclusion Criteria:
- intake of medicine likely to affect appetite or food intake;
- any medical condition involving the gastrointestinal tract;
- eating disorder;
- smoking;
- consumption of more than three cups of coffee per day;
- change of body weight more than 10% three months prior to screening;
- consumption of any restricted diet such as vegan, gluten free, slimming etc.;
- pregnancy, lactation or wish to become pregnant during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whole kernel breakfast
|
Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design
|
Placebo Comparator: Wheat reference breakfast
|
Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design
|
Active Comparator: Milled kernel breakfast
|
Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective appetite (hunger, satiety, desire to eat)
Time Frame: 8 hours
|
8 hours
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RPM537
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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