Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults.
BACKGROUND
Increased oxidative stress and inflammation are associated with aging, and contribute to an increased risk of chronic disease in older adults. Flaxseed lignans demonstrate antioxidant and anti-inflammatory activity, but their ability to reduce oxidative stress and inflammation markers in older adult populations has received limited investigation.


OBJECTIVE
This is a chronic intervention trial of community-dwelling healthy older adults to examine the effects of a flaxseed lignan (secoisolariciresinol diglucoside; SDG) enriched supplement (BeneFlax) compared to a placebo. The primary aim was to demonstrate the safety of BeneFlax and confirm its anti-inflammatory efficacy on markers of oxidative stress and inflammation, and subsequent functional outcomes, including those associated with its anti-inflammatory efficacy. A secondary aim was to determine flaxseed lignan metabolite concentrations in blood.


METHODS
A double-blind randomized clinical trial was conducted. Subjects were healthy community-dwelling adults aged 60-80 years. Testing was performed at baseline, 8, 16, and 24 weeks. The 24-week intervention consisted of 600 milligrams (mg) of SDG daily or an equivalent amount (volume) of placebo. All participants received 1000 international units of vitamin D to ensure adequate vitamin D status. Measurements consisted of blood pressure, hematology, and tolerability for safety assessments; blood oxidative stress and inflammatory biomarkers for efficacy; and cognition, muscle strength, and pain as functional outcomes. Secondary endpoints of plasma levels of lignan metabolites were analyzed by mass spectrometry. Other tests, such as bone turnover markers and fecal levels of flax cyclolinopeptides, will be performed at a later date.


RESULTS
Thirty-two participants were recruited (19 intervention and 13 control) and all completed the trial. Numerous Health Canada-imposed exclusion criteria limited recruitment success. Analyses are ongoing, but the baseline data available for a number of parameters indicate no differences between treatment groups. Safety measures (vital signs) did not change from baseline and were not significantly different between treatment and placebo groups at 24 weeks.


CONCLUSIONS
Preliminary results indicate that no safety concerns are associated with administering 600 mg SDG for 24 weeks to adults between the ages of 60 and 80 years.


BACKGROUND
Clinicaltrials.gov NCT01846117; https://clinicaltrials.gov/ct2/show/NCT01846117 (Archived by WebCite at http://www.webcitation.org/6nlDZNjmA).
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.
Jane
http://orcid.org/0000-0002-3473-2635
J
Alcorn
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.
Susan
http://orcid.org/0000-0002-7573-0425
S
Whiting
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.
Navita
http://orcid.org/0000-0001-8517-1332
N
Viveky
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.
Yunyun
http://orcid.org/0000-0003-4812-7142
Y
Di
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.
Kerry
http://orcid.org/0000-0002-3425-0425
K
Mansell
Division of Gastroenterology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.
Sharyle
http://orcid.org/0000-0002-2721-1591
S
Fowler
Community Health and Epidemiology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.
Lilian
http://orcid.org/0000-0003-2547-4205
L
Thorpe
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.
Ahmed
http://orcid.org/0000-0001-5183-1988
A
Almousa
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.
Pui Chi
http://orcid.org/0000-0002-2841-6177
PC
Cheng
Division of Gastroenterology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.
Jennifer
http://orcid.org/0000-0002-6380-6728
J
Jones
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.
Jennifer
http://orcid.org/0000-0003-2323-8524
J
Billinsky
Department of Psychology, Faculty of Arts, University of Regina, Regina, SK, Canada.
Thomas
http://orcid.org/0000-0002-8586-0450
T
Hadjistavropoulos
clinical trial; flax; inflammation; lignan; older adults; oxidative stress