Effect of Three Weeks Consumption of Rye Porridge Breakfast

Obesity Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01117363
• Other study ID #: SIV829
• Status: Active, not recruiting
• Phase: N/A
• First received: May 4, 2010
• Last updated: May 4, 2010
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: May 2010
• Source: Swedish University of Agricultural Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity Prevention

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Sweden	Good Food Practice	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Swedish University of Agricultural Sciences	Good Food Practice, Sweden, Lantmannen Research and Development

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	energy intake	Weighed food records was completed by the subjects during baseline and each intervention phase.	3 days	No
Secondary	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	No
Secondary	Breath hydrogen		8 h	No