Flaxseed Mucilage and Satiety (MUCISAT)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2010 by University of Copenhagen.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

University of Copenhagen

ClinicalTrials.gov Identifier:

NCT01238744

First received: November 10, 2010

Last updated: NA

Last verified: August 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	November 10, 2010
Last Updated Date	November 10, 2010
Start Date ^ICMJE	August 2009
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 10, 2010)	Appetite sensation [ Time Frame: 120 minutes ] [ Designated as safety issue: No ] Appetite sensation measured by visual analogue scales
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: November 10, 2010)	Energy intake [ Time Frame: 120 minutes ] [ Designated as safety issue: No ] Ad libitum energy intake at the next meal
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Flaxseed Mucilage and Satiety
Official Title ^ICMJE	Effect of Flaxseed Mucilage Drinks and Tablets on Satiety and Energy Intake
Brief Summary	The effect of a single dose of flaxseed mucilage incorporated into either drinks or tablets will be tested in term of their effect on appetite sensation measured using visual analogue scales over 120 minutes and ad libitum energy intake hereafter in two studies.
Detailed Description	Study I: Control drink vs. Flaxseed drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured. Study II: Flaxseed drink vs. Flaxseed tablets+control drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Appetite
Intervention ^ICMJE	Dietary Supplement: Flaxseed drink Drink containing flaxseed mucilage Dietary Supplement: Flaxseed tablet Tablets containing flaxseed mucilage consumed with a control drink Dietary Supplement: Control drink Control drink
Study Arm (s)	Placebo Comparator: Study I: control drink Intervention: Dietary Supplement: Control drink Experimental: Study I: flaxseed drink Intervention: Dietary Supplement: Flaxseed drink Active Comparator: Study II: flaxseed drink Intervention: Dietary Supplement: Flaxseed drink Experimental: Study II: flaxseed tablets Intervention: Dietary Supplement: Flaxseed tablet
Publications *	Not Provided
* 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	Active, not recruiting
Enrollment ^ICMJE	45
Estimated Completion Date	December 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: healthy adults 18-40 years BMI 19-28 Exclusion Criteria: smoking pregnancy or lactation excessive exercise medication (oral contraceptives the only exception)
Gender	Both
Ages	18 Years to 40 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	NCT01238744
Other Study ID Numbers ^ICMJE	B271
Has Data Monitoring Committee	No
Responsible Party	Mette Kristensen, Ass Prof, Department of Human Nutrition, University of Copenhagen
Study Sponsor ^ICMJE	University of Copenhagen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Copenhagen
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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