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Effect of Rye Bread Breakfasts on Eight Hour Satiety Ratings

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ClinicalTrials.gov Identifier: NCT00876785
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : April 14, 2009
Sponsor:
Collaborators:
Lantmännen R&D
Good Food Practice, Sweden
Information provided by:
Swedish University of Agricultural Sciences

Tracking Information
First Submitted Date  ICMJE April 6, 2009
First Posted Date  ICMJE April 7, 2009
Last Update Posted Date April 14, 2009
Study Start Date  ICMJE September 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
Subjective satiety, hunger and desire to eat [ Time Frame: During 8 hours after intake of test meal ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00876785 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Rye Bread Breakfasts on Eight Hour Satiety Ratings
Official Title  ICMJE Effect of Rye Bread Breakfasts on Subjective Hunger and Satiety
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
  • Other: wheat bread based breakfast
    Reference wheat bread breakfast
Study Arms  ICMJE
  • Active Comparator: 1
    Reference wheat bread breakfast
    Intervention: Other: wheat bread based breakfast
  • Experimental: 2
    Rye bread breakfast
    Intervention: Other: Rye bread breakfast
Publications * Isaksson H, Fredriksson H, Andersson R, Olsson J, Aman P. Effect of rye bread breakfasts on subjective hunger and satiety: a randomized controlled trial. Nutr J. 2009 Aug 26;8:39. doi: 10.1186/1475-2891-8-39.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2009)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00876785
Other Study ID Numbers  ICMJE SI829
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hanna Isaksson, lantmännen R&D
Study Sponsor  ICMJE Swedish University of Agricultural Sciences
Collaborators  ICMJE
  • Lantmännen R&D
  • Good Food Practice, Sweden
Investigators  ICMJE
Study Director: Per Aman, Professor university
PRS Account Swedish University of Agricultural Sciences
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP