- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01238744
Flaxseed Mucilage and Satiety (MUCISAT)
November 10, 2010 updated by: University of Copenhagen
Effect of Flaxseed Mucilage Drinks and Tablets on Satiety and Energy Intake
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy adults
- 18-40 years
- BMI 19-28
Exclusion Criteria:
- smoking
- pregnancy or lactation
- excessive exercise
- medication (oral contraceptives the only exception)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Study I: control drink
|
Control drink
|
Experimental: Study I: flaxseed drink
|
Drink containing flaxseed mucilage
|
Active Comparator: Study II: flaxseed drink
|
Drink containing flaxseed mucilage
|
Experimental: Study II: flaxseed tablets
|
Tablets containing flaxseed mucilage consumed with a control drink
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite sensation
Time Frame: 120 minutes
|
Appetite sensation measured by visual analogue scales
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy intake
Time Frame: 120 minutes
|
Ad libitum energy intake at the next meal
|
120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
November 10, 2010
First Submitted That Met QC Criteria
November 10, 2010
First Posted (Estimate)
November 11, 2010
Study Record Updates
Last Update Posted (Estimate)
November 11, 2010
Last Update Submitted That Met QC Criteria
November 10, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- B271
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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