ObesityHØRFRØNCT00953004
Flax Mucilage and Apparent Nutrient Digestibility
A study testing fiber drink and fiber bread in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- fiber drink and fiber bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2009to Dec 2009
- 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
- 18-40y
- BMI 22-28
- healthy
Who cannot join
- smoking
- medication
- excess PA
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department og Human Nutrition
Frederiksberg C, 1958
About this study
Official title: Effect of Flaxseed and Flaxseed Mucilage on Energy Digestibility, Lipid Profile and Appetite
The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults.
Read the detailed description
A 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. During the last five days, fecal samples are collected. Fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals.
- Conditions
- Obesity
- Being tested
- fiber drink and fiber bread
- Keywords
- dietary fiber, obesity, apparent energy digestibility
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiber drink and fiber breadDietary supplement
fiber drink or fiber bread three times daily
| Study group | Role | What they receive |
|---|---|---|
| fiber drink | Experimental | Not described Receives: Dietary Supplement: fiber drink and fiber bread |
| fiber bread | Experimental | Not described Receives: Dietary Supplement: fiber drink and fiber bread |
| placebo | Experimental | Not described Receives: Dietary Supplement: fiber drink and fiber bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat and energy digestibility
Measured: mean over period
Secondary outcomes (5)
appetite
Measured: three times daily
gastrointestinal distress
Measured: continously
lipid profile
Measured: end of each period
glucose and insulin
Measured: end of each period
fecal output and transit time
Measured: mean of each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Arne Astrup, PhD, Dr med, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953004
- Sponsor's protocol ID
- B245
- Acronym
- HØRFRØ
- Status last verified
- Aug 2009
- First submitted
- 17 Jul 2009
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kristensen M, Jensen MG, Aarestrup J, Petersen KE, Sondergaard L, Mikkelsen MS, Astrup A. Flaxseed dietary fibers lower cholesterol and increase fecal fat excretion, but magnitude of effect depend on food type. Nutr Metab (Lond). 2012 Feb 3;9:8. doi: 10.1186/1743-7075-9-8.
PubMed 22305169
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 and Flaxseed Mucilage on Energy Digestibility, Lipid Profile and Appetite
- ClinicalTrials.gov ID
- NCT00953004
- Acronym / sponsor ID
- HØRFRØ / B245
- Conditions
- Obesity
- Keywords
- dietary fiber, obesity, apparent energy digestibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 Aug 2009 (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 aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults.
Detailed description
A 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. During the last five days, fecal samples are collected. Fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fiber drink | Experimental | Dietary Supplement: fiber drink and fiber bread |
| fiber bread | Experimental | Dietary Supplement: fiber drink and fiber bread |
| placebo | Experimental | Dietary Supplement: fiber drink and fiber bread |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-40y
- BMI 22-28
- healthy
Key exclusion criteria (3 listed)
- smoking
- medication
- excess PA
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 |
|---|---|---|
| fiber drink and fiber breadfiber drink or fiber bread three times daily | Dietary supplement | fiber bread, fiber drink, placebo |
Primary outcome
Fat and energy digestibility
Time frame: mean over period
5 secondary outcomes
appetite
Time frame: three times daily
gastrointestinal distress
Time frame: continously
lipid profile
Time frame: end of each period
glucose and insulin
Time frame: end of each period
fecal output and transit time
Time frame: mean of each period
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.
- Derived from this study: PubMed 22305169Kristensen M, Jensen MG, Aarestrup J, Petersen KE, Sondergaard L, Mikkelsen MS, Astrup A. Flaxseed dietary fibers lower cholesterol and increase fecal fat excretion, but magnitude of effect depend on food type. Nutr Metab (Lond). 2012 Feb 3;9:8. doi: 10.1186/1743-7075-9-8.
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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.
Arne Astrup, PhD, Dr med principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fiber drink and fiber bread 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 3 inclusion and 3 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.
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?
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?
Fat and energy digestibility (time frame: mean over period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953004, which also lists 1 linked publication.
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.