Clinical trial NCT01117363: Effect of Three Weeks Consumption of Rye Porridge Breakfast
Official title: Effect of Three Weeks Consumption of Rye Porridge Breakfast on 24 h Appetite Profile, and Acute Effect on OCTT and Breath Hydrogen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity Prevention
Keywords: Appetite whole grain
Lead sponsor: Swedish University of Agricultural Sciences
Sponsor class: OTHER
Collaborators: name: Lantmannen Research and Development
name: Good Food Practice, Sweden
First posted: 2010-05-05
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Acute hunger-reducing effects (8h) has been documented for rye porridge breakfast compared with iso-caloric referenced refined wheat reference breakfast. The primary aim of the current study is to investigate whether this effects remains at regular consumption. A secondary aim is to compare the orocecal transit time (OCTT) between the two breakfasts.

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:

1. 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.
2. on day 8 during each intervention period, orocecal transit time and breath hydrogen will be measured after intake of the breakfast.
3. 3 day weighed food diaries will be taken at three occasions: at baseline and during the second week of each dietary intervention period.

Eligibility criteria: 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

Primary outcomes:
measure: Appetite profile
timeFrame: 24 h
Secondary outcomes:
measure: energy intake
timeFrame: 3 days
measure: Orocecal transit time
timeFrame: 8 h
measure: Breath hydrogen
timeFrame: 8 h
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Good Food Practice
Study officials:
affiliation: Swedish University of Agricultural Sciences
name: Per Åman, Professor
role: STUDY_DIRECTOR
References:
citation: Isaksson H, Tillander I, Andersson R, Olsson J, Fredriksson H, Webb DL, Aman P. Whole grain rye breakfast - sustained satiety during three weeks of regular consumption. Physiol Behav. 2012 Feb 1;105(3):877-84. doi: 10.1016/j.physbeh.2011.10.023. Epub 2011 Oct 28.