Clinical trial NCT02391779: Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension
Official title: Flaxseed Lignan Enriched Complex for Blood Pressure Reduction in Elderly Participants With High Normal Blood Pressure or Stage I Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: High normal blood pressure
Stage I
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in 24 h ambulatory systolic blood pressure
timeFrame: Baseline, week 4, and week 8
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline, week 4, and week 8
measure: Heart rate
timeFrame: Baseline
measure: Glucometer fasting blood glucose
timeFrame: Baseline
measure: Change in blood markers of safety and cardiovascular disease risk factors (clinical biochemical panel including fasting glucose, lipids, cholesterol, electrolytes, C-reactive protein)
timeFrame: Baseline, week 4, and week 8
measure: Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites
timeFrame: Week 4
measure: Physical activity assessment tool (PASE)
timeFrame: Baseline
measure: Block Food Frequency Questionnaire
timeFrame: Baseline
measure: Change in Body composition by DXA (Dual-energy X-ray absorptiometry)
timeFrame: Baseline, week 4, and week 8
measure: Heart Rate
timeFrame: week 4
measure: Heart Rate
timeFrame: Week 8
measure: Change in lying and standing blood pressure
timeFrame: Baseline, week 4, and week 8
measure: Respiratory rate
timeFrame: Baseline
measure: Respiratory rate
timeFrame: Week 4
measure: Respiratory rate
timeFrame: Week 8
measure: Block Food Frequency Questionnaire
timeFrame: Week 8
measure: Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites
timeFrame: Week 8
measure: Glucometer fasting blood glucose
timeFrame: Week 4
measure: Glucometer fasting blood glucose
timeFrame: Week 8
Other outcomes:
measure: Number of participants with adverse events as a safety measurement
timeFrame: Continuously throughout 9 weeks
measure: Number of participants with severe non-compliance with the protocol
timeFrame: Continuously throughout 9 weeks
Locations:
city: Saskatoon
country: Canada
facility: College of Pharmacy, University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Jane Alcorn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.