Appetite Profile After Intake of Rye Breakfast Meal

This study has been completed.

Sponsor:

Collaborator:

Lantmannen Research and Development

Information provided by:

Swedish University of Agricultural Sciences

ClinicalTrials.gov Identifier:

NCT01042418

First received: January 4, 2010

Last updated: NA

Last verified: January 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	January 4, 2010
Last Updated Date	January 4, 2010
Start Date ^ICMJE	October 2008
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 4, 2010)	Subjective appetite (hunger, satiety, desire to eat) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Appetite Profile After Intake of Rye Breakfast Meal
Official Title ^ICMJE	Appetite Profile After Intake of Rye Breakfast Meal
Brief 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.
Detailed 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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Condition ^ICMJE	Obesity Prevention
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Whole kernel breakfast Intervention: Other: Effect of breakfasts with whole vs milled rye kernels on appetite Placebo Comparator: Wheat reference breakfast Intervention: Other: Effect of breakfasts with whole vs milled rye kernels on appetite Active Comparator: Milled kernel breakfast Intervention: Other: Effect of breakfasts with whole vs milled rye kernels on appetite
Publications *	Isaksson H, Rakha A, Andersson R, Fredriksson H, Olsson J, Aman P. Rye kernel breakfast increases satiety in the afternoon - an effect of food structure. Nutr J. 2011 Apr 11;10:31.
* 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
Enrollment ^ICMJE	50
Completion Date	August 2009
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01042418
Other Study ID Numbers ^ICMJE	RPM537
Has Data Monitoring Committee	No
Responsible Party	Hanna Isaksson, Swedish University of Agricultural Sciences,
Study Sponsor ^ICMJE	Swedish University of Agricultural Sciences
Collaborators ^ICMJE	Lantmannen Research and Development
Investigators ^ICMJE	Not Provided
Information Provided By	Swedish University of Agricultural Sciences
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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