NCT02391779

Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BeneFlax®	Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training
BEHAVIORAL	Walking training	30-60 minutes walking training, 5 days/week.
BEHAVIORAL	Flexibility training	5 days/week; e.g. stretching training at home
DIETARY_SUPPLEMENT	Placebo (Whey Protein)	0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training
BEHAVIORAL	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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-03-18
• Last updated: 2018-01-10

Locations

1 site across 1 country: Canada