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HypertensionPhase 2NCT02391779

Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension

A Phase 2 study testing BeneFlax®, Walking training and Flexibility training in people with Hypertension, run by University of Saskatchewan at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Current recommendations today suggest that use of therapeutic lifestyle changes, such as supplementation with specific dietary components and moderate exercise, are appropriate interventions for individuals with borderline high blood pressure. Read more about this study

Who is it for?
Ages 60 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
BeneFlax®, Walking training and Flexibility training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteCanada
Study dates
May 2015to Jul 2017
Phase
Phase 2
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 60 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • High normal blood pressure (130/85 - 139/89) or stage I hypertension (140/90 - 150/90)
  • Ability to follow simple instructions

Who cannot join

  • Age below 60 years.
  • Individuals living in long term care homes.
  • Individuals unable to walk for 30 minutes.
  • Unstable diabetes, or diabetics taking insulin (note: eligible diabetic participants will undergo additional testing during the study ).
  • Current cancer or diagnosed with cancer in the past 2 years.
  • Significant liver or other gastrointestinal disorder including inflammatory bowel disease. (While constipation is the most common gastrointestinal problem in the elderly, it would not be a contraindication)
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  • Significant kidney disorder.
  • Have taken oral antibiotics in the past three months
  • Unstable or severe cardiac disease, recent myocardial infarction, or stroke (either in past 6 months or significantly affecting physical mobility).
  • Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder.
  • Migraine with aura within the last year (as this is a risk factor for stroke).
  • Current diagnosis of a bleeding condition, or at risk of bleeding.
  • Significant immune-compromise.
  • Current use of hormone replacement therapy (except thyroid).
  • Current use of blood pressure medications and/or diuretics
  • Current use of flax seed supplement
  • Participation in any other clinical trial with an investigational agent within one month prior to randomization.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • College of Pharmacy, University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 5E5

Other trials in Canada

About this study

Official title: Flaxseed Lignan Enriched Complex for Blood Pressure Reduction in Elderly Participants With High Normal Blood Pressure or Stage I Hypertension

Current recommendations today suggest that use of therapeutic lifestyle changes, such as supplementation with specific dietary components and moderate exercise, are appropriate interventions for individuals with borderline high blood pressure. Dietary intervention with natural products, such as flaxseed, is associated with decreased prevalence of cardiovascular disease (Adolphe 2010). Lignans are the active compounds in flaxseed believed to mediate the cardiovascular health benefits following flaxseed consumption (Peterson 2010). Clinical trials indicate benefit of Flax Lignan Enriched Complex (FLC) (BeneFlax® from Archer Daniels Midland, a natural product derived from flaxseed composed of 34-38% lignan) for reducing blood cholesterol and glucose (Pan 2007; Zhang 2008) and blood pressure (Cornish 2009). Furthermore, a recent study in atherosclerosis patients showed significant clinical benefit of flaxseed meal for reducing blood pressure (Rodriguez-Leyva 2013). As a therapeutic lifestyle change that could prevent a need to introduce drug therapy in elderly patients, the effectiveness of FLC supplementation alone or in combination with moderate exercise merits investigation.

Conditions
Hypertension
Being tested
BeneFlax®, Walking training, Flexibility training, Placebo (Whey Protein), Dash Eating Plan
Keywords
High normal blood pressure, Stage I
Medical subject headings
Hypertension

What participants receive

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

  • BeneFlax®Dietary supplement

    Also called Flaxseed lignan enriched complex

    Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training

  • Walking trainingBehavioural

    30-60 minutes walking training, 5 days/week.

  • Flexibility trainingBehavioural

    5 days/week; e.g. stretching training at home

  • Placebo (Whey Protein)Dietary supplement

    0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training

  • Dash Eating PlanBehavioural

    Dietary Approaches to Stop Hypertension (DASH), a balanced eating plan - all participants in all treatment arms will be encouraged to adopt a DASH eating plan.

Study groups in NCT02391779
Study groupRoleWhat they receive
BeneFlax® + walking training (Dash)ExperimentalBeneFlax (0.8 g, twice a day) with exercise training (30-60 minutes walking training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
Receives: Dietary Supplement: BeneFlax®; Behavioral: Walking training; Behavioral: Dash Eating Plan
Placebo + walking training (Dash)Placebo comparatorPlacebo (whey powder isocaloric to BeneFlax) with exercise training (30-60 minutes walking training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
Receives: Behavioral: Walking training; Dietary Supplement: Placebo (Whey Protein); Behavioral: Dash Eating Plan
BeneFlax® + flexibility training (Dash)ExperimentalBeneFlax (0.8 g, twice a day) with placebo exercise training (flexibility training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
Receives: Dietary Supplement: BeneFlax®; Behavioral: Flexibility training; Behavioral: Dash Eating Plan
Placebo + flexibility training (Dash)Sham comparatorPlacebo (whey powder isocaloric to BeneFlax) with placebo exercise training (flexibility training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
Receives: Behavioral: Walking training; Behavioral: Flexibility training; Behavioral: Dash Eating Plan

What is being measured

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

  1. Change in 24 h ambulatory systolic blood pressure

    Reduction in 24 h ambulatory systolic blood pressure at midpoint (week 4) and end (week 8) of the intervention relative to baseline value is the primary outcome of the intervention.

    Measured: Baseline, week 4, and week 8

Secondary outcomes (18)

  1. Change in body weight

    Change in body weight at midpoint (week 4) and end (week 8) of the intervention relative to baseline value.

    Measured: Baseline, week 4, and week 8

  2. Heart rate

    Measured: Baseline

  3. Glucometer fasting blood glucose

    Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.

    Measured: Baseline

  4. Change in blood markers of safety and cardiovascular disease risk factors (clinical biochemical panel including fasting glucose, lipids, cholesterol, electrolytes, C-reactive protein)

    These parameters will be measured individual but reviewed as a composite to confirm safety and any change in cardiovascular disease risk.

    Measured: Baseline, week 4, and week 8

  5. Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites

    Measured: Week 4

  6. Physical activity assessment tool (PASE)

    Measured: Baseline

  7. Block Food Frequency Questionnaire

    Measured: Baseline

  8. Change in Body composition by DXA (Dual-energy X-ray absorptiometry)

    Change in body composition at midpoint (week 4) and end (week 8) of the intervention relative to baseline value.

    Measured: Baseline, week 4, and week 8

  9. Heart Rate

    Measured: week 4

  10. Heart Rate

    Measured: Week 8

  11. Change in lying and standing blood pressure

    Change in lying and standing blood pressure at midpoint (week 4) and end (week 8) of the intervention relative to baseline value.

    Measured: Baseline, week 4, and week 8

  12. Respiratory rate

    Measured: Baseline

  13. Respiratory rate

    Measured: Week 4

  14. Respiratory rate

    Measured: Week 8

  15. Block Food Frequency Questionnaire

    Measured: Week 8

  16. Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites

    Measured: Week 8

  17. Glucometer fasting blood glucose

    Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.

    Measured: Week 4

  18. Glucometer fasting blood glucose

    Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.

    Measured: Week 8

Timeline

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

  1. First posted18 Mar 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJul 2017
  4. Study completionJul 2017

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02391779
Sponsor's protocol ID
FSL132
Status last verified
Jan 2018
First submitted
28 Feb 2015
Last updated
10 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • Peterson J, Dwyer J, Adlercreutz H, Scalbert A, Jacques P, McCullough ML. Dietary lignans: physiology and potential for cardiovascular disease risk reduction. Nutr Rev. 2010 Oct;68(10):571-603. doi: 10.1111/j.1753-4887.2010.00319.x.

    PubMed 20883417

  • Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS One. 2007 Nov 7;2(11):e1148. doi: 10.1371/journal.pone.0001148.

    PubMed 17987126

  • Zhang W, Wang X, Liu Y, Tian H, Flickinger B, Empie MW, Sun SZ. Dietary flaxseed lignan extract lowers plasma cholesterol and glucose concentrations in hypercholesterolaemic subjects. Br J Nutr. 2008 Jun;99(6):1301-9. doi: 10.1017/S0007114507871649. Epub 2007 Dec 6.

    PubMed 18053310

  • Cornish SM, Chilibeck PD, Paus-Jennsen L, Biem HJ, Khozani T, Senanayake V, Vatanparast H, Little JP, Whiting SJ, Pahwa P. A randomized controlled trial of the effects of flaxseed lignan complex on metabolic syndrome composite score and bone mineral in older adults. Appl Physiol Nutr Metab. 2009 Apr;34(2):89-98. doi: 10.1139/H08-142.

    PubMed 19370038

  • 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

  • Adolphe JL, Whiting SJ, Juurlink BH, Thorpe LU, Alcorn J. Health effects with consumption of the flax lignan secoisolariciresinol diglucoside. Br J Nutr. 2010 Apr;103(7):929-38. doi: 10.1017/S0007114509992753. Epub 2009 Dec 15.

    PubMed 20003621

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BeneFlax®, Walking training and Flexibility training in people with Hypertension, 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 2 inclusion and 17 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 10 Jan 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change in 24 h ambulatory systolic blood pressure (time frame: Baseline, week 4, and week 8). 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 NCT02391779, which also lists 6 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 10 Jan 2018.

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