Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension
- Conditions
- Hypertension
- Interventions
- Behavioral: Walking trainingDietary Supplement: BeneFlax®Behavioral: Flexibility trainingDietary Supplement: Placebo (Whey Protein)Behavioral: Dash Eating Plan
- Registration Number
- NCT02391779
- Lead Sponsor
- University of Saskatchewan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- High normal blood pressure (130/85 - 139/89) or stage I hypertension (140/90 - 150/90)
- Ability to follow simple instructions
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Placebo + walking training (Dash) Walking training 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® + walking training (Dash) BeneFlax® 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. BeneFlax® + walking training (Dash) Dash Eating Plan 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. BeneFlax® + walking training (Dash) Walking training 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. BeneFlax® + flexibility training (Dash) Flexibility training 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) 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. Placebo + walking training (Dash) Placebo (Whey Protein) 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. Placebo + walking training (Dash) 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. Placebo + flexibility training (Dash) Flexibility training 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. BeneFlax® + flexibility training (Dash) BeneFlax® 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. BeneFlax® + flexibility training (Dash) 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. Placebo + flexibility training (Dash) Walking training 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Heart rate Baseline Glucometer fasting blood glucose Week 8 Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.
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.
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.
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.
Block Food Frequency Questionnaire Week 8 Heart Rate Week 8 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 8 Physical activity assessment tool (PASE) Baseline Respiratory rate Week 8
Trial Locations
- Locations (1)
College of Pharmacy, University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada