A Phase 2 interventional study of BeneFlax® and Walking training in Hypertension, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by University of Saskatchewan · Phase 2, Interventional, and Treatment
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Saskatchewan is the lead sponsor of 243 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: BeneFlax® · Behavioral: Walking training · Behavioral: Dash Eating Plan
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.
Behavioral: Walking training · Dietary Supplement: Placebo (Whey Protein) · Behavioral: Dash Eating Plan
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.
Dietary Supplement: BeneFlax® · Behavioral: Flexibility training · Behavioral: Dash Eating Plan
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.
Behavioral: Walking training · Behavioral: Flexibility training · Behavioral: 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
Also known as: Flaxseed lignan enriched complex
30-60 minutes walking training, 5 days/week.
5 days/week; e.g. stretching training at home
0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training
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.
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.
Time frame: Baseline, week 4, and week 8
Change in body weight
Change in body weight at midpoint (week 4) and end (week 8) of the intervention relative to baseline value.
Time frame: Baseline, week 4, and week 8
Heart rate
Time frame: Baseline
Glucometer fasting blood glucose
Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.
Time frame: Baseline
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.
Time frame: Baseline, week 4, and week 8
Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites
Time frame: Week 4
Physical activity assessment tool (PASE)
Time frame: Baseline
Block Food Frequency Questionnaire
Time frame: Baseline
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.
Time frame: Baseline, week 4, and week 8
Heart Rate
Time frame: week 4
Heart Rate
Time frame: Week 8
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.
Time frame: Baseline, week 4, and week 8
Respiratory rate
Time frame: Baseline
Respiratory rate
Time frame: Week 4
Respiratory rate
Time frame: Week 8
Block Food Frequency Questionnaire
Time frame: Week 8
Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites
Time frame: Week 8
Glucometer fasting blood glucose
Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.
Time frame: Week 4
Glucometer fasting blood glucose
Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.
Time frame: Week 8
Number of participants with adverse events as a safety measurement
Time frame: Continuously throughout 9 weeks
Number of participants with severe non-compliance with the protocol
Time frame: Continuously throughout 9 weeks
The record gives a start of May 2015, a primary completion of Jul 2017 and a completion of Jul 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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