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Completed

NCT Number: NCT02391779

Flaxseed Lignan Supplementation in Elderly Participants With 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

College of Pharmacy, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

BeneFlax®

Dietary Supplement

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

Other names: Flaxseed lignan enriched complex

walking training

Behavioral

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

Flexibility Training

Behavioral

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 Plan

Behavioral

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.

Primary outcomes

  1. Change in 24 h ambulatory systolic blood pressure

    Time frame: Baseline, week 4, and week 8

    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.

Secondary outcomes

  1. Change in body weight

    Time frame: Baseline, week 4, and week 8

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

  2. Heart rate

    Time frame: Baseline

  3. Glucometer fasting blood glucose

    Time frame: Baseline

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

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

    Time frame: Baseline, week 4, and week 8

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

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

    Time frame: Week 4

  6. Physical activity assessment tool (PASE)

    Time frame: Baseline

  7. Block Food Frequency Questionnaire

    Time frame: Baseline

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

    Time frame: Baseline, week 4, and week 8

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

  9. Heart Rate

    Time frame: week 4

  10. Heart Rate

    Time frame: Week 8

  11. Change in lying and standing blood pressure

    Time frame: Baseline, week 4, and week 8

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

  12. Respiratory rate

    Time frame: Baseline

  13. Respiratory rate

    Time frame: Week 4

  14. Respiratory rate

    Time frame: Week 8

  15. Block Food Frequency Questionnaire

    Time frame: Week 8

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

    Time frame: Week 8

  17. Glucometer fasting blood glucose

    Time frame: Week 4

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

  18. Glucometer fasting blood glucose

    Time frame: Week 8

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

Other outcomes

  1. Number of participants with adverse events as a safety measurement

    Time frame: Continuously throughout 9 weeks

  2. Number of participants with severe non-compliance with the protocol

    Time frame: Continuously throughout 9 weeks

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2015
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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