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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01042418
Other study ID # RPM537
Secondary ID
Status Completed
Phase N/A
First received January 4, 2010
Last updated January 4, 2010
Start date October 2008
Est. completion date August 2009

Study information

Verified date January 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

Food structure influence metabolic response including appetite. Whole grain foods include a wide range of products; cracked or cut kernels, rolled flakes or milled to flour and used in foods such as breads, breakfast cereals and pasta.


Description:

The aim of the present study was to investigate if rye grain structure influence perceived appetite. A comparison of whole rye kernels and milled rye kernels were done in two study parts. In the first part the rye was served as porridge breakfasts and in the second one milled and whole kernels were included into bread breakfasts. In order to observe potential effects that would arise when the remains of the meal reaches the colon, the period of measurement was set to 8 h after intake of iso-caloric rye bread and rye porridge breakfasts.

A randomized, crossover design was used to compare the effects of iso-caloric breakfast meals on subjective appetite during 8 h after consumption.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- 20 and 60 years;

- body mass index (BMI) 18-27 kg/m2;

- habit of consuming breakfast, lunch and dinner every day

- 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 of body weight more than 10% three months prior to screening;

- consumption of any restricted diet such as vegan, gluten free, slimming etc.;

- pregnancy, lactation or wish to become pregnant during the study period

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Effect of breakfasts with whole vs milled rye kernels on appetite
Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Swedish University of Agricultural Sciences Lantmannen Research and Development

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective appetite (hunger, satiety, desire to eat) 8 hours No
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