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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BeneFlax® + walking training (Dash) | Experimental | 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. |
|
| Placebo + walking training (Dash) | Placebo Comparator | 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. |
|
| BeneFlax® + flexibility training (Dash) | Experimental | 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. |
|
| Placebo + flexibility training (Dash) | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 4, and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a safety measurement | Continuously throughout 9 weeks | |
| Number of participants with severe non-compliance with the protocol | Continuously throughout 9 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Alcorn, PhD | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Pharmacy, University of Saskatchewan | Saskatoon | Saskatchewan | S7N 5E5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20883417 | Background | 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. | |
| 17987126 | Background | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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|
| 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. |
|
| Glucometer fasting blood glucose | 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) | 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 | Week 4 |
| Physical activity assessment tool (PASE) | Baseline |
| Block Food Frequency Questionnaire | 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. | Baseline, week 4, and week 8 |
| Heart Rate | week 4 |
| Heart Rate | 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. | Baseline, week 4, and week 8 |
| Respiratory rate | Baseline |
| Respiratory rate | Week 4 |
| Respiratory rate | Week 8 |
| Block Food Frequency Questionnaire | Week 8 |
| Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites | Week 8 |
| Glucometer fasting blood glucose | Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia. | Week 4 |
| Glucometer fasting blood glucose | Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia. | Week 8 |
| 18053310 | Background | 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. |
| 19370038 | Background | 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. |
| 24126178 | Background | 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. |
| 20003621 | Background | 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. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |