Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391779
• Other study ID #: FSL132
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2015
• Last updated: January 8, 2018
• Start date: May 2015
• Est. completion date: July 2017

Study information

• Verified date: January 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	College of Pharmacy, University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Epub 2007 Dec 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events as a safety measurement		Continuously throughout 9 weeks
Other	Number of participants with severe non-compliance with the protocol		Continuously throughout 9 weeks
Primary	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	Change in body weight	Change in body weight at midpoint (week 4) and end (week 8) of the intervention relative to baseline value.	Baseline, week 4, and week 8
Secondary	Heart rate		Baseline
Secondary	Glucometer fasting blood glucose	Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.	Baseline
Secondary	Change in blood markers of safety and cardiovascular disease risk factors (clinical biochemical panel including fasting glucose, lipids, cholesterol, electrolytes, C-reactive protein)	These parameters will be measured individual but reviewed as a composite to confirm safety and any change in cardiovascular disease risk.	Baseline, week 4, and week 8
Secondary	Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites		Week 4
Secondary	Physical activity assessment tool (PASE)		Baseline
Secondary	Block Food Frequency Questionnaire		Baseline
Secondary	Change in Body composition by DXA (Dual-energy X-ray absorptiometry)	Change in body composition at midpoint (week 4) and end (week 8) of the intervention relative to baseline value.	Baseline, week 4, and week 8
Secondary	Heart Rate		week 4
Secondary	Heart Rate		Week 8
Secondary	Change in lying and standing blood pressure	Change in lying and standing blood pressure at midpoint (week 4) and end (week 8) of the intervention relative to baseline value.	Baseline, week 4, and week 8
Secondary	Respiratory rate		Baseline
Secondary	Respiratory rate		Week 4
Secondary	Respiratory rate		Week 8
Secondary	Block Food Frequency Questionnaire		Week 8
Secondary	Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites		Week 8
Secondary	Glucometer fasting blood glucose	Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.	Week 4
Secondary	Glucometer fasting blood glucose	Diabetes only; Blood glucose monitored to ensure intervention does not result in hypoglycemia.	Week 8