- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02391779
Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension
January 8, 2018 updated by: Jane Alcorn, University of Saskatchewan
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 5E5
- College of Pharmacy, University of Saskatchewan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BeneFlax® + walking training (Dash)
BeneFlax (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.
|
Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training
Other Names:
30-60 minutes walking training, 5 days/week.
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.
|
Placebo Comparator: Placebo + walking training (Dash)
Placebo (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.
|
30-60 minutes walking training, 5 days/week.
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.
0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training
|
Experimental: BeneFlax® + flexibility training (Dash)
BeneFlax (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.
|
Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training
Other Names:
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.
5 days/week; e.g.
stretching training at home
|
Sham Comparator: Placebo + flexibility training (Dash)
Placebo (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.
|
30-60 minutes walking training, 5 days/week.
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.
5 days/week; e.g.
stretching training at home
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, week 4, and week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, week 4, and week 8
|
Heart rate
Time Frame: Baseline
|
Baseline
|
|
Glucometer fasting blood glucose
Time Frame: Baseline
|
Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.
|
Baseline
|
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.
|
Baseline, week 4, and week 8
|
Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites
Time Frame: Week 4
|
Week 4
|
|
Physical activity assessment tool (PASE)
Time Frame: Baseline
|
Baseline
|
|
Block Food Frequency Questionnaire
Time Frame: Baseline
|
Baseline
|
|
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.
|
Baseline, week 4, and week 8
|
Heart Rate
Time Frame: week 4
|
week 4
|
|
Heart Rate
Time Frame: Week 8
|
Week 8
|
|
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.
|
Baseline, week 4, and week 8
|
Respiratory rate
Time Frame: Baseline
|
Baseline
|
|
Respiratory rate
Time Frame: Week 4
|
Week 4
|
|
Respiratory rate
Time Frame: Week 8
|
Week 8
|
|
Block Food Frequency Questionnaire
Time Frame: Week 8
|
Week 8
|
|
Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites
Time Frame: Week 8
|
Week 8
|
|
Glucometer fasting blood glucose
Time Frame: Week 4
|
Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.
|
Week 4
|
Glucometer fasting blood glucose
Time Frame: Week 8
|
Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.
|
Week 8
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events as a safety measurement
Time Frame: Continuously throughout 9 weeks
|
Continuously throughout 9 weeks
|
Number of participants with severe non-compliance with the protocol
Time Frame: Continuously throughout 9 weeks
|
Continuously throughout 9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
February 28, 2015
First Submitted That Met QC Criteria
March 12, 2015
First Posted (Estimate)
March 18, 2015
Study Record Updates
Last Update Posted (Actual)
January 10, 2018
Last Update Submitted That Met QC Criteria
January 8, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FSL132
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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