Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension

University of Saskatchewan

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Behavioral: Dash Eating Plan; Dietary Supplement: BeneFlax®; Dietary Supplement: Placebo (Whey Protein); Behavioral: Flexibility training; Behavioral: Walking training

Study type: Interventional

Funder types: Other

Identifiers

NCT02391779

FSL132

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

BeneFlax® + walking training (Dash)

Experimental group

Description:

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.

Treatment:

Behavioral: Dash Eating Plan

Behavioral: Walking training

Dietary Supplement: BeneFlax®

Placebo + walking training (Dash)

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Dash Eating Plan

Behavioral: Walking training

Dietary Supplement: Placebo (Whey Protein)

BeneFlax® + flexibility training (Dash)

Experimental group

Description:

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.

Treatment:

Behavioral: Dash Eating Plan

Behavioral: Flexibility training

Dietary Supplement: BeneFlax®

Placebo + flexibility training (Dash)

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Dash Eating Plan

Behavioral: Flexibility training

Behavioral: Walking training