Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Flaxseed Lignan Enriched Complex for Blood Pressure Reduction in Elderly Participants With High Normal Blood Pressure or Stage I Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: BeneFlax®
* Behavioral: Walking training
* Behavioral: Flexibility training
* Dietary Supplement: Placebo (Whey Protein)
* Behavioral: Dash Eating Plan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BeneFlax® + walking training (Dash)<br>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®<br>* Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training<br>* Other names: Flaxseed lignan enriched complex;Behavioral: Walking training<br>* 30-60 minutes walking training, 5 days/week.<br>Behavioral: Dash Eating Plan<br>* 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.<br>|
| Placebo Comparator: Placebo + walking training (Dash)<br>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<br>* 30-60 minutes walking training, 5 days/week.<br>Dietary Supplement: Placebo (Whey Protein)<br>* 0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training<br>Behavioral: Dash Eating Plan<br>* 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.<br>|
| Experimental: BeneFlax® + flexibility training (Dash)<br>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®<br>* Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training<br>* Other names: Flaxseed lignan enriched complex;Behavioral: Flexibility training<br>* 5 days/week; e.g. stretching training at home<br>Behavioral: Dash Eating Plan<br>* 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.<br>|
| Sham Comparator: Placebo + flexibility training (Dash)<br>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<br>* 30-60 minutes walking training, 5 days/week.<br>Behavioral: Flexibility training<br>* 5 days/week; e.g. stretching training at home<br>Behavioral: Dash Eating Plan<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High normal blood pressure, Stage I