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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Appetite sensation measured by visual analogue scales


Secondary Outcome Measures:
  • Energy intake [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: November 10, 2010
Last Updated: November 10, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

ClinicalTrials.gov processed this record on August 28, 2014