Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-07-31

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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BeneFlax® + walking training (Dash)

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.

Group Type EXPERIMENTAL

BeneFlax®

Intervention Type DIETARY_SUPPLEMENT

Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training

Walking training

Intervention Type BEHAVIORAL

30-60 minutes walking training, 5 days/week.

Dash Eating Plan

Intervention Type 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.

Placebo + walking training (Dash)

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.

Group Type PLACEBO_COMPARATOR

Walking training

Intervention Type BEHAVIORAL

30-60 minutes walking training, 5 days/week.

Placebo (Whey Protein)

Intervention Type DIETARY_SUPPLEMENT

0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training

Dash Eating Plan

Intervention Type 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.

BeneFlax® + flexibility training (Dash)

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.

Group Type EXPERIMENTAL

BeneFlax®

Intervention Type DIETARY_SUPPLEMENT

Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training

Flexibility training

Intervention Type BEHAVIORAL

5 days/week; e.g. stretching training at home

Dash Eating Plan

Intervention Type 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.

Placebo + flexibility training (Dash)

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.

Group Type SHAM_COMPARATOR

Walking training

Intervention Type BEHAVIORAL

30-60 minutes walking training, 5 days/week.

Flexibility training

Intervention Type BEHAVIORAL

5 days/week; e.g. stretching training at home

Dash Eating Plan

Intervention Type 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.

Interventions

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BeneFlax®

Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training

Intervention Type DIETARY_SUPPLEMENT

Walking training

30-60 minutes walking training, 5 days/week.

Intervention Type BEHAVIORAL

Flexibility training

5 days/week; e.g. stretching training at home

Intervention Type BEHAVIORAL

Placebo (Whey Protein)

0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training

Intervention Type DIETARY_SUPPLEMENT

Dash 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Flaxseed lignan enriched complex

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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes