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Flaxseed Mucilage and Satiety (MUCISAT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by University of Copenhagen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238744
First Posted: November 11, 2010
Last Update Posted: November 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Copenhagen
  Purpose
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.

Condition Intervention
Appetite Dietary Supplement: Flaxseed drink Dietary Supplement: Flaxseed tablet Dietary Supplement: Control drink

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Flaxseed Mucilage Drinks and Tablets on Satiety and Energy Intake

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Appetite sensation [ Time Frame: 120 minutes ]
    Appetite sensation measured by visual analogue scales


Secondary Outcome Measures:
  • Energy intake [ Time Frame: 120 minutes ]
    Ad libitum energy intake at the next meal


Enrollment: 45
Study Start Date: August 2009
Estimated Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Study I: control drink Dietary Supplement: Control drink
Control drink
Experimental: Study I: flaxseed drink Dietary Supplement: Flaxseed drink
Drink containing flaxseed mucilage
Active Comparator: Study II: flaxseed drink Dietary Supplement: Flaxseed drink
Drink containing flaxseed mucilage
Experimental: Study II: flaxseed tablets Dietary Supplement: Flaxseed tablet
Tablets containing flaxseed mucilage consumed with a control drink

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults
  • 18-40 years
  • BMI 19-28

Exclusion Criteria:

  • smoking
  • pregnancy or lactation
  • excessive exercise
  • medication (oral contraceptives the only exception)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Mette Kristensen, Ass Prof, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01238744     History of Changes
Other Study ID Numbers: B271
First Submitted: November 10, 2010
First Posted: November 11, 2010
Last Update Posted: November 11, 2010
Last Verified: August 2010