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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01117363
Other study ID # SIV829
Secondary ID
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


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
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