Familial or Severe HypercholesterolemiaPhase 3NCT01007344
Flaxseed Compared With Placebo in Patients With Hypercholesterolemia
A Phase 3 study testing flaxseed and whole wheat flour in people with Familial or Severe Hypercholesterolemia, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared to those on placebo. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Familial or Severe Hypercholesterolemia
- What is being tested?
- flaxseed and whole wheat flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Dec 2010
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 8 to 18 years
- positive first-degree family history of hypercholesterolemia or premature atherosclerotic cardiovascular disease
- elevated LDL level above 3.5 mmol/L and less than 5.0 mmol/L
- entered in the National Cholesterol Education Program Step II diet for at least 6 months
Who cannot join
- patients with secondary causes of hyperlipidemia
- history of major illness or surgery 3 months or less prior to enrollment
- taking lipid-lowering medications
- history of gastrointestinal problems
- allergies towards flaxseed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo
The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared to those on placebo.
Read the detailed description
The proposed study is a 4 week randomized, double-blind, placebo-controlled clinical trial. Participants will be recruited from the pediatric lipid disorder clinic at the Hospital for Sick Children, which provides consultations to and management of children with primary lipid abnormalities. Patients that meet the study criteria will be approached during their routinely scheduled clinic visits, until the sample size (N=30) be reached. Patients will randomly be assigned to the intervention or the placebo group. The intervention group will be given muffins and breads containing ground flaxseed. Two muffins and one slice of bread will be consumed per day to provide a total of 30g flaxseed to the experimental group. The control group will be given muffins and breads containing whole wheat flour in place of flaxseed. Participants will be instructed to eat one muffin for breakfast, one muffin as an afternoon snack, and one slice of bread as an evening snack every day for a 4-week period. The muffins and breads use in the study will be baked by an independent baker.
- Conditions
- Familial or Severe Hypercholesterolemia
- Being tested
- flaxseed, whole wheat flour
- Keywords
- flaxseed, hypercholesterolemia, children
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flaxseedDietary supplement
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
whole wheat flourDietary supplement
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| flaxseed | Active comparator | 2 muffins and 1 slice of bread for a total of 30g flaxseed per day Receives: Dietary Supplement: flaxseed |
| whole wheat flour | Placebo comparator | 2 muffins and 1 slice of bread containing whole wheat flour per day Receives: Dietary Supplement: whole wheat flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein
Measured: 4 weeks
Secondary outcomes (2)
LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione
Measured: 4 weeks
complete blood count
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2010
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 Familial or Severe HypercholesterolemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian McCrindle, The Hospital for Sick Children
- Investigators
- Brian McCrindle, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007344
- Sponsor's protocol ID
- 1000008297
- Status last verified
- Aug 2013
- First submitted
- 3 Nov 2009
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong H, Chahal N, Manlhiot C, Niedra E, McCrindle BW. Flaxseed in pediatric hyperlipidemia: a placebo-controlled, blinded, randomized clinical trial of dietary flaxseed supplementation for children and adolescents with hypercholesterolemia. JAMA Pediatr. 2013 Aug 1;167(8):708-13. doi: 10.1001/jamapediatrics.2013.1442.
PubMed 23733031
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo
- ClinicalTrials.gov ID
- NCT01007344
- Acronym / sponsor ID
- 1000008297
- Conditions
- Familial or Severe Hypercholesterolemia
- Keywords
- flaxseed, hypercholesterolemia, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Nov 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 of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared to those on placebo.
Detailed description
The proposed study is a 4 week randomized, double-blind, placebo-controlled clinical trial. Participants will be recruited from the pediatric lipid disorder clinic at the Hospital for Sick Children, which provides consultations to and management of children with primary lipid abnormalities. Patients that meet the study criteria will be approached during their routinely scheduled clinic visits, until the sample size (N=30) be reached. Patients will randomly be assigned to the intervention or the placebo group. The intervention group will be given muffins and breads containing ground flaxseed. Two muffins and one slice of bread will be consumed per day to provide a total of 30g flaxseed to the experimental group. The control group will be given muffins and breads containing whole wheat flour in place of flaxseed. Participants will be instructed to eat one muffin for breakfast, one muffin as an afternoon snack, and one slice of bread as an evening snack every day for a 4-week period. The muffins and breads use in the study will be baked by an independent baker.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flaxseed | Active comparator | Dietary Supplement: flaxseed2 muffins and 1 slice of bread for a total of 30g flaxseed per day |
| whole wheat flour | Placebo comparator | Dietary Supplement: whole wheat flour2 muffins and 1 slice of bread containing whole wheat flour per day |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age 8 to 18 years
- positive first-degree family history of hypercholesterolemia or premature atherosclerotic cardiovascular disease
- elevated LDL level above 3.5 mmol/L and less than 5.0 mmol/L
- entered in the National Cholesterol Education Program Step II diet for at least 6 months
Key exclusion criteria (5 listed)
- patients with secondary causes of hyperlipidemia
- history of major illness or surgery 3 months or less prior to enrollment
- taking lipid-lowering medications
- history of gastrointestinal problems
- allergies towards flaxseed
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 |
|---|---|---|
| flaxseed1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks | Dietary supplement | flaxseed |
| whole wheat flour1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks | Dietary supplement | whole wheat flour |
Primary outcome
fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein
Time frame: 4 weeks
2 secondary outcomes
LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione
Time frame: 4 weeks
complete blood count
Time frame: 4 weeks
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 27 Aug 2013.
- Derived from this study: PubMed 23733031Wong H, Chahal N, Manlhiot C, Niedra E, McCrindle BW. Flaxseed in pediatric hyperlipidemia: a placebo-controlled, blinded, randomized clinical trial of dietary flaxseed supplementation for children and adolescents with hypercholesterolemia. JAMA Pediatr. 2013 Aug 1;167(8):708-13. doi: 10.1001/jamapediatrics.2013.1442.
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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.
Brian McCrindle, MD principal investigator
The Hospital for Sick Children
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 flaxseed and whole wheat flour in people with Familial or Severe Hypercholesterolemia, run by The Hospital for Sick Children 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 4 inclusion and 5 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 27 Aug 2013. 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?
fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein (time frame: 4 weeks). 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 NCT01007344, 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 27 Aug 2013; AzTrials last refreshed its copy on 26 Oct 2026.