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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00876785
Other study ID # SI829
Secondary ID
Status Completed
Phase N/A
First received April 6, 2009
Last updated April 13, 2009
Start date September 2007
Est. completion date May 2008

Study information

Verified date April 2009
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

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date May 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Other:
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.
wheat bread based breakfast
Reference wheat bread breakfast

Locations

Country Name City State
Sweden Swedish University of Agricultural Sciences Uppsala

Sponsors (3)

Lead Sponsor Collaborator
Swedish University of Agricultural Sciences Good Food Practice, Sweden, Lantmännen R&D

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective satiety, hunger and desire to eat During 8 hours after intake of test meal No
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