- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01117363
Effect of Three Weeks Consumption of Rye Porridge Breakfast
Effect of Three Weeks Consumption of Rye Porridge Breakfast on 24 h Appetite Profile, and Acute Effect on OCTT and Breath Hydrogen
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is randomised and cross-over. During two 3-wk periods, separated by a 3-4-wks wash out, subjects will consume test breakfasts. During one of the periods test breakfast includes rye flake porridge and during the other period test breakfast include bread made from sifted wheat. The breakfast meals will be similar in calorie-, protein-, carbohydrate- and fat content. For all other days but 1, 8 and 22 of respective test period, the breakfast foods will be handed out to the participants along with instructions to exchange their ordinary breakfast with the test foods. During day 1, 8 and 22 the breakfasts will be served at the study centre.
Following measurements will be made:
- Subjective ratings of hunger, satiety and desire to eat during 24 h after breakfast on day 1, 8 and 22 during each 3-wk intervention period.
- on day 8 during each intervention period, orocecal transit time and breath hydrogen will be measured after intake of the breakfast.
- 3 day weighed food diaries will be taken at three occasions: at baseline and during the second week of each dietary intervention period.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Uppsala, Sweden, 75183
- Good Food Practice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- man or woman aged between 20 and 60 years;
- body mass index (BMI) 18-27 kg/m2;
- habit of consuming breakfast, lunch and dinner every day;
- and 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 in body weight more than 10% during three months prior to screening;
- consumption of any restricted diet such as vegan, gluten-free, slimming;
- pregnancy, lactation or wish to become pregnant during the study period;
- any known intolerance towards salazopyrin and similar substances
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rye porrige breakfast
|
A breakfast consisting of either active (rye porridge) or control (wheat bread) is given during 2 3-wk intervention periods in a randomized cross-over design.
The two dietary intervention periods are separated by a 3-4 wks wash out.
|
Active Comparator: Refined wheat reference bread breakfast
|
A breakfast consisting of either active (rye porridge) or control (wheat bread) is given during 2 3-wk intervention periods in a randomized cross-over design.
The two dietary intervention periods are separated by a 3-4 wks wash out.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite profile
Time Frame: 24 h
|
Subjective feelings of appetite (hunger, satiety and desire to eat) were assessed every 30 min, starting just before breakfast at 08:00 and continuing until bedtime.
The last recording was made before breakfast on the following day.
|
24 h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
energy intake
Time Frame: 3 days
|
Weighed food records was completed by the subjects during baseline and each intervention phase.
|
3 days
|
Orocecal transit time
Time Frame: 8 h
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Salazopyrin (two 500 mg tabelts) is taken after breakfast.
The substance passes the stomach and small intestine unabsorbed and is broken down by microbial fermentation in the colon to sulphapyridine and 5-ASA.
Sulphapyridine appearance in the blood is then measured as an indicator of colon arrival time.
|
8 h
|
Breath hydrogen
Time Frame: 8 h
|
8 h
|
Collaborators and Investigators
Investigators
- Study Director: Per Åman, Professor, Swedish University of Agricultural Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- SIV829
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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