Hypertension
Conditions
Keywords
High normal blood pressure, Stage I
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTBeneFlax®
Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training
BEHAVIORALWalking training
30-60 minutes walking training, 5 days/week.
BEHAVIORALFlexibility training
5 days/week; e.g. stretching training at home
DIETARY_SUPPLEMENTPlacebo (Whey Protein)
0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training
BEHAVIORALDash Eating Plan
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.
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24 h ambulatory systolic blood pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | 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. |
| Heart rate | Baseline | — |
| Glucometer fasting blood glucose | Baseline | Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia. |
| Change in blood markers of safety and cardiovascular disease risk factors (clinical biochemical panel including fasting glucose, lipids, cholesterol, electrolytes, C-reactive protein) | 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. |
| Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites | Week 4 | — |
| Physical activity assessment tool (PASE) | Baseline | — |
| Change in lying and standing blood pressure | 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. |
| Respiratory rate | Baseline | — |
| Block Food Frequency Questionnaire | Baseline | — |
| Change in Body composition by DXA (Dual-energy X-ray absorptiometry) | 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. |
| Heart Rate | week 4 | — |
Other
| Measure | 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 |
Countries
Canada
Outcome results
None listed