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HypertensionPhase 2/3NCT01952340

The Efficacy of Dietary Flaxseed for the Reduction of Blood Pressure in Newly Diagnosed Hypertensive Individuals

A Phase 2/3 study testing Flaxseed in people with Hypertension, run by St. Boniface Hospital at 3 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The World Health Organization has deemed high blood pressure as a global crisis because it is the number one risk factor associated with most deaths worldwide. Therefore, the need for effective and desirable treatment options is vitally necessary. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hypertension
What is being tested?
Flaxseed
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
3 sitesCanada
Study dates
Jul 2014to 5 Dec 2020
Phase
Phase 2/3
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Essential hypertension (average automated systolic blood pressure of 135-160 OR diastolic blood pressure of 85-100)
  • Newly diagnosed. Defined as being clinically diagnosed within the last 6 months. This includes the screening examination.
  • Either gender
  • Untreated for hypertension
  • 18-85 years old and able to provide informed consent.
  • Females who are:
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  • highly unlikely to conceive due to surgical sterilization
  • postmenopausal female with >2 years since last menses
  • or non-sterilized, premenopausal female who agrees to: 1. Use an adequate method of contraception to prevent pregnancy (such as a double-barrier method or hormonal); 2. Abstain from heterosexual activity for study period; or 3. Only engage in heterosexual activity with surgically sterilized male partner(s) and not planning on becoming pregnant during the study. Please note that a pregnancy test will NOT be administered for the trial.
  • Subjects taking anti-platelet therapy must be on a stable dose for 3 months prior to the study.
  • Subjects taking lipid lowering drugs must be on a stable dose for 3 months prior to the study.
  • Subjects must have access to freezer space in their residence to hold up to one month of frozen food products associated with this study.

Who cannot join

  • Patients with ischemic pain at rest in limbs, ulceration, or gangrene.
  • Clinical evidence of peripheral artery disease, previous myocardial infarction, or stroke.
  • Patient has undergone percutaneous coronary angioplasty, has had coronary bypass within the last 6 months, or has unstable angina.
  • Known secondary hypertension of any etiology.
  • Patients with confirmed and clinically significant renal or hepatic abnormalities (creatinine > 0.130 mM or creatinine clearance < 45ml/min, AST 2-3x normal, ALT > 2-3x normal) and/or electrolyte imbalance serum K+ < 3.5 or > 5.5 mM.
  • History of major bleeding.
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  • Patients with diabetes mellitus, bowel disease (including Crohn's disease, celiac disease, colitis, peptic ulcer disease, irritable bowel syndrome and diverticulosis) or other diseases such as active systemic lupus erythematosus, cancer, or end stage respiratory disease.
  • Patients with macrovascular target organ damage, including: cerebrovascular disease, stroke, dementia, hypertensive retinopathy, left ventricular dysfunction, angina pectoris, myocardial infarction, renal disease, and peripheral artery disease.
  • Patients with clinical evidence of heart failure or an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with an ejection fraction < 40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures).
  • Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study. Please see point 11 below.
  • Subjects ingesting more than 2 servings of fish per week, taking omega-3 fatty acid supplements, and/or consuming milled flaxseed or flax oil on a regular basis (ie: ≥ 1 tablespoon of milled flaxseed or 1 teaspoon of flax oil per week). If the patient chooses to, they may exclude these supplements for 4 weeks as a washout period before entry into the trial.
  • Patients having participated in an investigational drug program in the preceding 30 days or unable or unwilling to comply with the protocol.
  • Subjects with allergies to any ingredient in the study product or placebo (including gluten).
  • Patients who will undergo surgery or intend to move well outside Winnipeg during the trial period.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • St. Boniface Hospital Research Centre

    Winnipeg, Manitoba, R2H 2A6

  • South Sherbrook Health Centre

    Winnipeg, Manitoba, R3C 2B3

  • Health Sciences Centre Hospital

    Winnipeg, Manitoba, R3E0Z3

Other trials in Canada

About this study

Official title: A Phase II/III, Randomized, Double-Blinded, Controlled Clinical Trial to Investigate the Efficacy of Dietary Flaxseed for the Reduction of Blood Pressure in Newly Diagnosed Hypertensive Individuals

The World Health Organization has deemed high blood pressure as a global crisis because it is the number one risk factor associated with most deaths worldwide. Therefore, the need for effective and desirable treatment options is vitally necessary. The purpose of the current investigation is to determine the efficacy of a new therapeutic strategy: flaxseed. The aim is to determine the efficacy of consuming milled flaxseed every day for 6 months on the reduction of blood pressure in individuals newly diagnosed with high blood pressure yet to receive any blood pressure lowering medications. Secondary objectives are to understand how flaxseed at the molecular level can reduce blood pressure. The study hypothesis is that the flaxseed group will exhibit significant reductions in blood pressure and therefore not require any blood pressure lowering medication. The aim is to provide knowledge on a new therapeutic strategy to help manage high blood pressure.

Read the detailed description

This trial is a phase II/III, randomized, double-blinded, controlled clinical trial to determine the efficacy of dietary flaxseed as a therapeutic strategy to reduce blood pressure in newly diagnosed hypertensive individuals. The aim of the trial is to recruit 100 participants that have been clinically diagnosed with hypertension within 6 months and yet to receive any anti-hypertensive medication. The control and flax groups will be provided food products to consume on a daily basis for 6 months. Assessment parameters such as averaged automated blood pressure, anthropometrics, 24-food recall, physical activity questionnaire, and blood and urine analysis will be conducted at baseline, 2, 4, and 6 months.

Conditions
Hypertension
Being tested
Flaxseed, Placebo
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FlaxseedDietary supplement

    Milled flaxseed

  • PlaceboDietary supplement

    Wheat germ/wheat bran and mixed dietary oils

Study groups in NCT01952340
Study groupRoleWhat they receive
FlaxseedExperimental30 grams of milled flaxseed on its own or baked into food products (ie: bagels, muffins, and snack bars)
Receives: Dietary Supplement: Flaxseed
Wheat/Mixed Dietary OilsPlacebo comparatorA combination of wheat, pecans, and/or mixed dietary oils on its own or baked into food products (ie: bagels, muffins, and snack bars)
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. averaged automated blood pressure

    Measured: Baseline, 2, 4, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2013 (estimated)
  2. Study startJul 2014
  3. Primary completion5 Dec 2020
  4. Study completion5 Dec 2020

Why it stopped: Premature termination because: a) the COVID-19 pandemic stopped recruitment or participation for 2 years which limited study numbers, and, b) both PI's will retire and, therefore, will be unable to oversee the trial.

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01952340
Sponsor's protocol ID
HF2013
Other IDs
B2013:079
Status last verified
May 2022
First submitted
24 Sep 2013
Last updated
6 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Rodriguez-Leyva D, Weighell W, Edel AL, LaVallee R, Dibrov E, Pinneker R, Maddaford TG, Ramjiawan B, Aliani M, Guzman R, Pierce GN. Potent antihypertensive action of dietary flaxseed in hypertensive patients. Hypertension. 2013 Dec;62(6):1081-9. doi: 10.1161/HYPERTENSIONAHA.113.02094. Epub 2013 Oct 14.

    PubMed 24126178

  • Caligiuri SP, Penner B, Pierce GN. The HYPERFlax trial for determining the anti-HYPERtensive effects of dietary flaxseed in newly diagnosed stage 1 hypertensive patients: study protocol for a randomized, double-blinded, controlled clinical trial. Trials. 2014 Jun 18;15:232. doi: 10.1186/1745-6215-15-232.

    PubMed 24938224

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Flaxseed in people with Hypertension, run by St. Boniface Hospital at 3 sites 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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Premature termination because: a) the COVID-19 pandemic stopped recruitment or participation for 2 years which limited study numbers, and, b) both PI's will retire and, therefore, will be unable to oversee the trial.). 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?

averaged automated blood pressure (time frame: Baseline, 2, 4, and 6 months). 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 NCT01952340, which also lists 2 linked publications.

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 6 May 2022.

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