- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876785
Effect of Rye Bread Breakfasts on Eight Hour Satiety Ratings
April 13, 2009 updated by: Swedish University of Agricultural Sciences
Effect of Rye Bread Breakfasts on Subjective Hunger and Satiety
The aim of the present study was to investigate subjective appetite during 8 hours after intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Energy-dense foods that require little effort to consume and that are rapidly digested may cause passive over-consumption by failure to provide a feeling of fullness corresponding to the energy content.
A diet that is predominantly based on such foods may lead to overweight.
It is therefore important to identify properties of foods that facilitate energy balance by creating a high satiety per calorie.
A number of studies have confirmed that foods naturally rich in dietary fiber promote the feeling of fullness and reduce hunger in the short term.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Uppsala, Sweden, 75007
- Swedish University of Agricultural Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age between 20 and 60 years
- body mass index (BMI) 18-27 kg/m2
- a habit of consuming breakfast, lunch and dinner everyday
- fasting plasma glucose 4.0-6.1 mmol/L
- haemoglobin (Hb) in men 130-170 g/L, in women 120-150 g/L
- thyroid-stimulating hormone (TSH) 0.3-4.0 mlE/L
- 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 of 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Reference wheat bread breakfast
|
Reference wheat bread breakfast
|
|
Experimental: 2
Rye bread breakfast
|
A randomised, within-subject comparison design was used.
Appetite (hunger, satiety and desire to eat) was rated regularly from just before breakfast at 08:00 until 16:00.
Amount, type and timing of food and drink intake during the study period were standardised.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Subjective satiety, hunger and desire to eat
Time Frame: During 8 hours after intake of test meal
|
During 8 hours after intake of test meal
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Per Aman, Professor, University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
April 6, 2009
First Submitted That Met QC Criteria
April 6, 2009
First Posted (Estimate)
April 7, 2009
Study Record Updates
Last Update Posted (Estimate)
April 14, 2009
Last Update Submitted That Met QC Criteria
April 13, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SI829
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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