Effect of Three Weeks Consumption of Rye Porridge Breakfast

Study Overview
=================
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: 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.

Official Title
-----------------
Effect of Three Weeks Consumption of Rye Porridge Breakfast on 24 h Appetite Profile, and Acute Effect on OCTT and Breath Hydrogen

Conditions
-----------------
Obesity Prevention

Intervention / Treatment
-----------------
* Other: dietary intervention (rye porridge or wheat bread)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rye porrige breakfast<br> | Other: dietary intervention (rye porridge or wheat bread)<br>* 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.<br>|
| Active Comparator: Refined wheat reference bread breakfast<br> | Other: dietary intervention (rye porridge or wheat bread)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite profile | 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 | Weighed food records was completed by the subjects during baseline and each intervention phase. | 3 days | 
| Orocecal transit time | 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 |  | 8 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appetite whole grain