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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training
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.
College of Pharmacy, University of Saskatchewan
Saskatoon, Saskatchewan, Canada
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
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