ObesityNCT00465036
Effect of Flaxseed on Lipid Uptake and Appetite
A study testing Whole flaxseeds, flaxseed mucilage, glucomannan in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Randomized trial to test the effect of flaxseed fractions on appetite regulation and intestinal lipid absorption. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Whole flaxseeds, flaxseed mucilage, glucomannan
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2006to Oct 2007
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males aged 18-40 years
- Normal weight or moderately overweigh (BMI 25-30 kg/m2)
Who cannot join
- Blood drawing/donation less than six months prior to start of the study
- Hemoglobin concentration <8mmol/L
- Chronic diseases (i.e. diabetes, CVD), hypertension, hyperlipidemia
- Consumption of dietary supplements including vitamin tablets
- Smoking
- Excess physical activity (>10h of intense physical activity per week)
- Medicine use (not including occasional consumption of pain killers)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole Flaxseeds and Flaxseed Mucilage on Lipid Absorption, Glucose and Insulin Metabolism and Appetite Regulation
Randomized trial to test the effect of flaxseed fractions on appetite regulation and intestinal lipid absorption.
Read the detailed description
Randomized multiple crossover trial in 18 healthy males aged 18 to 40 years each are required to complete a total of five iso-caloric meal tests lasting approximately 8½ hours. Test meals will be given as breakfast meals, in which different fractions of flaxseeds are incorporated into baked products. Appetite will be registered using visual analogue scales during 7 hours after the test meal and a total of 10 blood samples will be drawn to evaluate TAG in chylomicrons, plasma LDL, HDL and total cholesterol, plasma TAG, insulin, glucose and appetite hormone levels. At the end of the test day an ad libitum meal will be served and food intake registered.
- Conditions
- Obesity
- Being tested
- Whole flaxseeds, flaxseed mucilage, glucomannan
- Keywords
- fat absorption, fibres
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole flaxseeds, flaxseed mucilage, glucomannanDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
TAG in chylomicrons
serum TAG
HDL, LDL and total cholesterol
appetite scores
ad libium food intake
appetite hormone levels
Secondary outcomes (6)
free fatty acid profile
plasma glucose
plasma insulin
meal macronutrient composition
meal energy content
meal pleasantness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startOct 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Søren Toubro, MD, Principal investigator, Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465036
- Sponsor's protocol ID
- KF 01 309595
- Other IDs
- B226
- Status last verified
- Mar 2009
- First submitted
- 23 Apr 2007
- Last updated
- 26 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Flaxseeds and Flaxseed Mucilage on Lipid Absorption, Glucose and Insulin Metabolism and Appetite Regulation
- ClinicalTrials.gov ID
- NCT00465036
- Acronym / sponsor ID
- KF 01 309595
- Conditions
- Obesity
- Keywords
- fat absorption, fibres
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 24 Apr 2007 (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.
Randomized trial to test the effect of flaxseed fractions on appetite regulation and intestinal lipid absorption.
Detailed description
Randomized multiple crossover trial in 18 healthy males aged 18 to 40 years each are required to complete a total of five iso-caloric meal tests lasting approximately 8½ hours. Test meals will be given as breakfast meals, in which different fractions of flaxseeds are incorporated into baked products. Appetite will be registered using visual analogue scales during 7 hours after the test meal and a total of 10 blood samples will be drawn to evaluate TAG in chylomicrons, plasma LDL, HDL and total cholesterol, plasma TAG, insulin, glucose and appetite hormone levels. At the end of the test day an ad libitum meal will be served and food intake registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males aged 18-40 years
- Normal weight or moderately overweigh (BMI 25-30 kg/m2)
Key exclusion criteria (7 listed)
- Blood drawing/donation less than six months prior to start of the study
- Hemoglobin concentration <8mmol/L
- Chronic diseases (i.e. diabetes, CVD), hypertension, hyperlipidemia
- Consumption of dietary supplements including vitamin tablets
- Smoking
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 |
|---|---|---|
| Whole flaxseeds, flaxseed mucilage, glucomannan | Dietary supplement | – |
Primary outcome
TAG in chylomicrons
serum TAG
HDL, LDL and total cholesterol
appetite scores
ad libium food intake
appetite hormone levels
6 secondary outcomes
free fatty acid profile
plasma glucose
plasma insulin
meal macronutrient composition
meal energy content
meal pleasantness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2009.
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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.
Søren Toubro, MD principal investigator
Institute of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole flaxseeds, flaxseed mucilage, glucomannan in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 26 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TAG in chylomicrons. The study lists 6 primary outcomes in all. 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 26 Mar 2009.