Metabolic SyndromePhase 3NCT00204412
Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol
A Phase 3 study testing Flax lignan and Exercise (walking) in people with Metabolic Syndrome and Osteoporosis, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The purpose of our study is to use a flaxseed-based nutritional supplement in combination with exercise training (walking) for improving cholesterol levels. We hypothesize that exercise training will improve cholesterol profile and that adding supplementation with a flaxseed nutritional supplement will further improve… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Osteoporosis
- What is being tested?
- Flax lignan and Exercise (walking)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2005to Mar 2006
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years or older
Who cannot join
- Currently taking medication for cholesterol
- Smoker
- Diabetic
- Gastrointestinal disease
- Females on hormone replacement therapy
- Currently taking a flaxseed supplement
- Currently engaged in vigorous exercise training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles
The purpose of our study is to use a flaxseed-based nutritional supplement in combination with exercise training (walking) for improving cholesterol levels. We hypothesize that exercise training will improve cholesterol profile and that adding supplementation with a flaxseed nutritional supplement will further improve cholesterol profile.
Read the detailed description
Flax supplementation and exercise training each have small beneficial effects for improving blood lipid profile and reducing cardiovascular disease risk. Flax lignan, a phytoestrogen found in flaxseed is thought to be the active compound responsible for the cholesterol-lowering effect of flaxseed. Our purpose is to combine an exercise training program (walking) with flax lignan supplementation for improving blood lipid profile.
Comparisons: Walking (6 days per week) plus flax lignan (500 mg per day) compared to walking plus placebo.
- Conditions
- Metabolic Syndrome, Osteoporosis
- Being tested
- Flax lignan, Exercise (walking)
- Keywords
- Cholesterol, High density lipoprotein, Low density lipoprotein, Triglyceride, Glucose, Exercise, Fitness, Flax, Lignan, Phytoestrogen, bone
- Medical subject headings
- Metabolic Syndrome, Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flax lignanDietary supplement
Also called Archer Daniels Midland
543 mg SDG per day
Exercise (walking)Behavioural
walking 45 minutes per day 5 days per week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | flax lignan Receives: Dietary Supplement: Flax lignan; Behavioral: Exercise (walking) |
| 2 | Placebo comparator | placebo Receives: Dietary Supplement: Flax lignan |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic syndrome score
Measured: 6 months
Secondary outcomes (14)
Total cholesterol at 2, 4, and 6 months
Measured: 6 months
High density lipoprotein at 2, 4, and 6 months
Measured: 6 months
Low density lipoprotein at 2, 4, and 6 months
Measured: 6 months
Triglycerides at 2, 4, and 6 months
Measured: 6 months
Blood glucose at 2, 4, and 6 months
Measured: 6 months
Body composition at 6 months
Measured: 6 months
Aerobic fitness at 6 months
Measured: 6 months
Waist Girth at 6 months
Measured: 6 months
Body mass index at 6 months
Measured: 6 months
Lumbar spine bone mineral density at 6 months
Measured: 6 months
Proximal femur bone mineral density at 6 months
Measured: 6 months
Whole body bone mineral density at 6 months
Measured: 6 months
Trunk fat skinfolds at 6 months
Measured: 6 months
inflammatory cytokines
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Investigators
- Philip D Chilibeck, PhD, Principal investigator, University of SaskatchewanH J Biem, MD, Study director, University of SaskatchewanLisa Paus-Jenssen, MD, Study director, University of SaskatchewanSusan Whiting, PhD, Study director, University of SaskatchewanPunam Pahwa, PhD, Study director, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204412
- Sponsor's protocol ID
- 686868
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 5 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles
- ClinicalTrials.gov ID
- NCT00204412
- Acronym / sponsor ID
- 686868
- Conditions
- Metabolic Syndrome, Osteoporosis
- Keywords
- Cholesterol, High density lipoprotein, Low density lipoprotein, Triglyceride, Glucose, Exercise, Fitness, Flax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Mar 2005
- Study completion
- Mar 2006 (actual)
- First posted
- 20 Sep 2005 (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 purpose of our study is to use a flaxseed-based nutritional supplement in combination with exercise training (walking) for improving cholesterol levels. We hypothesize that exercise training will improve cholesterol profile and that adding supplementation with a flaxseed nutritional supplement will further improve cholesterol profile.
Detailed description
Flax supplementation and exercise training each have small beneficial effects for improving blood lipid profile and reducing cardiovascular disease risk. Flax lignan, a phytoestrogen found in flaxseed is thought to be the active compound responsible for the cholesterol-lowering effect of flaxseed. Our purpose is to combine an exercise training program (walking) with flax lignan supplementation for improving blood lipid profile.
Comparisons: Walking (6 days per week) plus flax lignan (500 mg per day) compared to walking plus placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Flax lignan, Behavioral: Exercise (walking)flax lignan |
| 2 | Placebo comparator | Dietary Supplement: Flax lignanplacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 50 years or older
Key exclusion criteria (7 listed)
- Currently taking medication for cholesterol
- Smoker
- Diabetic
- Gastrointestinal disease
- Females on hormone replacement therapy
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 |
|---|---|---|
| Flax lignanAlso: Archer Daniels Midland543 mg SDG per day | Dietary supplement | 1, 2 |
| Exercise (walking)walking 45 minutes per day 5 days per week | Behavioural | 1 |
Primary outcome
metabolic syndrome score
Time frame: 6 months
14 secondary outcomes
Total cholesterol at 2, 4, and 6 months
Time frame: 6 months
High density lipoprotein at 2, 4, and 6 months
Time frame: 6 months
Low density lipoprotein at 2, 4, and 6 months
Time frame: 6 months
Triglycerides at 2, 4, and 6 months
Time frame: 6 months
Blood glucose at 2, 4, and 6 months
Time frame: 6 months
Body composition at 6 months
Time frame: 6 months
Aerobic fitness at 6 months
Time frame: 6 months
Waist Girth at 6 months
Time frame: 6 months
Body mass index at 6 months
Time frame: 6 months
Lumbar spine bone mineral density at 6 months
Time frame: 6 months
Proximal femur bone mineral density at 6 months
Time frame: 6 months
Whole body bone mineral density at 6 months
Time frame: 6 months
Trunk fat skinfolds at 6 months
Time frame: 6 months
inflammatory cytokines
Time frame: 6 months
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 5 Nov 2007.
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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.
Philip D Chilibeck, PhD principal investigator
University of Saskatchewan
H J Biem, MD study director
University of Saskatchewan
Lisa Paus-Jenssen, MD study director
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flax lignan and Exercise (walking) in people with Metabolic Syndrome and Osteoporosis, run by University of Saskatchewan at 1 site in Canada.
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 1 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 5 Nov 2007. 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 Canada. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
metabolic syndrome score (time frame: 6 months). 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 5 Nov 2007.