Overview

This trial is active, not recruiting.

Condition obesity prevention
Treatment dietary intervention (rye porridge or wheat bread)
Sponsor Swedish University of Agricultural Sciences
Collaborator Lantmannen Research and Development
Start date March 2010
End date July 2010
Trial size 26 participants
Trial identifier NCT01117363, SIV829

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
dietary intervention (rye porridge or wheat bread)
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)
dietary intervention (rye porridge or wheat bread)
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.

Primary Outcomes

Measure
Appetite profile
time frame: 24 h

Secondary Outcomes

Measure
energy intake
time frame: 3 days
Orocecal transit time
time frame: 8 h
Breath hydrogen
time frame: 8 h

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title Effect of Three Weeks Consumption of Rye Porridge Breakfast on 24 h Appetite Profile, and Acute Effect on OCTT and Breath Hydrogen
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Swedish University of Agricultural Sciences.