Clinical trial NCT01846117: Once-Daily Oral Dose of BeneFlax to Healthy Older Adults
Official title: Once-Daily Oral Dose of BeneFlax to Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Oxidative Stress
Inflammation
Aging
Pain
Keywords: lignans
oxidative stress
inflammation
aging
muscle weakness
pain
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
First posted: 2013-05-03
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are investigating whether the flax lignan, secoisolariciresinol diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to be broken down in the body to produce the health benefits of flax. Flax lignan is separated from the whole flax seed as this compound is believed to have health effects. Decreasing oxidative stress and inflammation should improve a number of the problems associated with aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an equivalent amount of whey protein.

The investigators are comparing lignan to a placebo (whey powder) to examine whether a dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and inflammation.


Eligibility criteria: Inclusion Criteria:

* Male or female adult 60 to 80 years residing in Saskatoon.
* Able to comply with study protocol.
* Able to follow simple instructions.

Exclusion Criteria:

* Age below 60 or above 80 years at initiation of the study.
* Individuals living in long term care homes.
* Individuals at risk of hypotension or with symptomatic hypotension.
* Fasting hypoglycemia.
* 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.
* Women with an immediate family history or personal history of breast cancer or ovarian cancer.
* 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.
* 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 immunocompromise.
* Other unstable conditions.
* Current use of hormone replacement therapy (except thyroid medication is allowed).
* Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
* Intolerances or allergies to flax or vitamin D.
* Allergy to whey
* Surgery within the last six months.
* Participation in any other clinical trial with an investigational agent within one month prior to randomization.

Primary outcomes:
measure: Safety of consumption of 600 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)
timeFrame: 24 weeks
Secondary outcomes:
measure: Effect of SDG on blood lipids
timeFrame: 24 weeks
measure: Effect of SDG on inflammation
timeFrame: 24 weeks
measure: Effect of SDG on quality of life
timeFrame: 24 weeks
measure: Effect of SDG supplement on blood levels of flax lignan metabolites
timeFrame: 24 weeks
measure: Effect of SDG supplement on fecal levels of flax lignan metabolites
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Saskatoon Centre for Patient-Oriented Research
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Jennifer Jones, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan
name: Jane Alcorn, DVD, PhD
role: STUDY_CHAIR
affiliation: University of Saskatchewan
name: Susan Whiting, PhD
role: STUDY_CHAIR
affiliation: University of Saskatchewan
name: Kerry Mansell, BSP, PharmD
role: STUDY_CHAIR
affiliation: University of Saskatchewan
name: Sharyle Fowler, MD
role: STUDY_CHAIR
affiliation: University of Saskatchewan
name: Lilian Thorpe, MD, PhD
role: STUDY_CHAIR
affiliation: University of Regina
name: Thomas Hadjistavropoulos, PhD, RD
role: STUDY_CHAIR
References:
citation: Alcorn J, Whiting S, Viveky N, Di Y, Mansell K, Fowler S, Thorpe L, Almousa A, Cheng PC, Jones J, Billinsky J, Hadjistavropoulos T. Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults. JMIR Res Protoc. 2017 Feb 3;6(2):e14. doi: 10.2196/resprot.6817.