Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension

NCT02391779 | Completed Phase 2

• 1 other identifier: FSL132
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

High normal blood pressure; Stage I

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Change in body weight

  Baseline, week 4, and week 8

• Heart rate

  Baseline

• Glucometer fasting blood glucose

  Baseline

• 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

• Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites

  Week 4

Other Outcomes (2)

• Number of participants with adverse events as a safety measurement

  Continuously throughout 9 weeks

• Number of participants with severe non-compliance with the protocol

  Continuously throughout 9 weeks

Study Arms (4)

BeneFlax® + walking training (Dash)

EXPERIMENTAL

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®; Behavioral: Walking training; Behavioral: Dash Eating Plan

Placebo + walking training (Dash)

PLACEBO COMPARATOR

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; Dietary Supplement: Placebo (Whey Protein); Behavioral: Dash Eating Plan

BeneFlax® + flexibility training (Dash)

EXPERIMENTAL

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®; Behavioral: Flexibility training; Behavioral: Dash Eating Plan

Placebo + flexibility training (Dash)

SHAM COMPARATOR

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; Behavioral: Flexibility training; Behavioral: Dash Eating Plan

Interventions

BeneFlax® DIETARY_SUPPLEMENT

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

Also known as: Flaxseed lignan enriched complex

BeneFlax® + flexibility training (Dash); BeneFlax® + walking training (Dash)

Walking training BEHAVIORAL

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

BeneFlax® + walking training (Dash); Placebo + flexibility training (Dash); Placebo + walking training (Dash)

Flexibility training BEHAVIORAL

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

BeneFlax® + flexibility training (Dash); Placebo + flexibility training (Dash)

Placebo (Whey Protein) DIETARY_SUPPLEMENT

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

Placebo + walking training (Dash)

Dash Eating Plan 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® + walking training (Dash); Placebo + flexibility training (Dash); Placebo + walking training (Dash)

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High normal blood pressure (130/85 - 139/89) or stage I hypertension (140/90 - 150/90)
• Ability to follow simple instructions

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

College of Pharmacy, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E5, Canada

Location

Related Publications (6)

• Peterson J, Dwyer J, Adlercreutz H, Scalbert A, Jacques P, McCullough ML. Dietary lignans: physiology and potential for cardiovascular disease risk reduction. Nutr Rev. 2010 Oct;68(10):571-603. doi: 10.1111/j.1753-4887.2010.00319.x.

  PMID: 20883417 BACKGROUND

• Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS One. 2007 Nov 7;2(11):e1148. doi: 10.1371/journal.pone.0001148.

  PMID: 17987126 BACKGROUND

• Zhang W, Wang X, Liu Y, Tian H, Flickinger B, Empie MW, Sun SZ. Dietary flaxseed lignan extract lowers plasma cholesterol and glucose concentrations in hypercholesterolaemic subjects. Br J Nutr. 2008 Jun;99(6):1301-9. doi: 10.1017/S0007114507871649. Epub 2007 Dec 6.

  PMID: 18053310 BACKGROUND

• Cornish SM, Chilibeck PD, Paus-Jennsen L, Biem HJ, Khozani T, Senanayake V, Vatanparast H, Little JP, Whiting SJ, Pahwa P. A randomized controlled trial of the effects of flaxseed lignan complex on metabolic syndrome composite score and bone mineral in older adults. Appl Physiol Nutr Metab. 2009 Apr;34(2):89-98. doi: 10.1139/H08-142.

  PMID: 19370038 BACKGROUND

• Rodriguez-Leyva D, Weighell W, Edel AL, LaVallee R, Dibrov E, Pinneker R, Maddaford TG, Ramjiawan B, Aliani M, Guzman R, Pierce GN. Potent antihypertensive action of dietary flaxseed in hypertensive patients. Hypertension. 2013 Dec;62(6):1081-9. doi: 10.1161/HYPERTENSIONAHA.113.02094. Epub 2013 Oct 14.

  PMID: 24126178 BACKGROUND

• Adolphe JL, Whiting SJ, Juurlink BH, Thorpe LU, Alcorn J. Health effects with consumption of the flax lignan secoisolariciresinol diglucoside. Br J Nutr. 2010 Apr;103(7):929-38. doi: 10.1017/S0007114509992753. Epub 2009 Dec 15.

  PMID: 20003621 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jane Alcorn, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 28, 2015
• First Posted: March 18, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

CA (1)