AppetiteMUCISATNCT01238744
Flaxseed Mucilage and Satiety
A study testing Flaxseed drink and Flaxseed tablet in people with Appetite, run by University of Copenhagen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- Flaxseed drink and Flaxseed tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults
- 18-40 years
- BMI 19-28
Who cannot join
- smoking
- pregnancy or lactation
- excessive exercise
- medication (oral contraceptives the only exception)
About this study
Official title: 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.
Read the 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.
- Conditions
- Appetite
- Being tested
- Flaxseed drink, Flaxseed tablet, Control drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaxseed drinkDietary supplement
Drink containing flaxseed mucilage
Flaxseed drinkDietary supplement
Drink containing flaxseed mucilage
Flaxseed tabletDietary supplement
Tablets containing flaxseed mucilage consumed with a control drink
Control drinkDietary supplement
Control drink
| Study group | Role | What they receive |
|---|---|---|
| Study I: control drink | Placebo comparator | Not described Receives: Dietary Supplement: Control drink |
| Study I: flaxseed drink | Experimental | Not described Receives: Dietary Supplement: Flaxseed drink |
| Study II: flaxseed drink | Active comparator | Not described Receives: Dietary Supplement: Flaxseed drink |
| Study II: flaxseed tablets | Experimental | Not described Receives: Dietary Supplement: Flaxseed tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite sensation
Appetite sensation measured by visual analogue scales
Measured: 120 minutes
Secondary outcomes (1)
Energy intake
Ad libitum energy intake at the next meal
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238744
- Sponsor's protocol ID
- B271
- Acronym
- MUCISAT
- Status last verified
- Aug 2010
- First submitted
- 10 Nov 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flaxseed Mucilage Drinks and Tablets on Satiety and Energy Intake
- ClinicalTrials.gov ID
- NCT01238744
- Acronym / sponsor ID
- MUCISAT / B271
- Conditions
- Appetite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study I: control drink | Placebo comparator | Dietary Supplement: Control drink |
| Study I: flaxseed drink | Experimental | Dietary Supplement: Flaxseed drink |
| Study II: flaxseed drink | Active comparator | Dietary Supplement: Flaxseed drink |
| Study II: flaxseed tablets | Experimental | Dietary Supplement: Flaxseed tablet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy adults
- 18-40 years
- BMI 19-28
Key exclusion criteria (4 listed)
- smoking
- pregnancy or lactation
- excessive exercise
- medication (oral contraceptives the only exception)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flaxseed drinkDrink containing flaxseed mucilage | Dietary supplement | Study I: flaxseed drink |
| Flaxseed drinkDrink containing flaxseed mucilage | Dietary supplement | Study II: flaxseed drink |
| Flaxseed tabletTablets containing flaxseed mucilage consumed with a control drink | Dietary supplement | Study II: flaxseed tablets |
| Control drinkControl drink | Dietary supplement | Study I: control drink |
Primary outcome
Appetite sensation
Time frame: 120 minutes
Appetite sensation measured by visual analogue scales
1 secondary outcome
Energy intake
Time frame: 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed drink and Flaxseed tablet in people with Appetite, run by University of Copenhagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite sensation (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2010.