Status:
COMPLETED
Once-Daily Oral Dose of BeneFlax to Healthy Older Adults
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Saskatchewan Health Research Foundation
Conditions:
Oxidative Stress
Inflammation
Eligibility:
All Genders
60-80 years
Phase:
PHASE1
PHASE2
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 bo...
Eligibility Criteria
Inclusion
- Male or female adult 60 to 80 years residing in Saskatoon.
- Able to comply with study protocol.
- Able to follow simple instructions.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01846117
Start Date
April 1 2013
End Date
November 1 2014
Last Update
June 14 2018
Active Locations (1)
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1
Saskatoon Centre for Patient-Oriented Research
Saskatoon, Saskatchewan, Canada, S7K 0M7