Status:
COMPLETED
Oxidative Stress and Nutritional Supplementation Intervention Study
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Saskatchewan Health Research Foundation
Conditions:
Oxidative Stress
Inflammation
Eligibility:
All Genders
60-80 years
Phase:
PHASE2
Brief Summary
A major means whereby oxidative stress promotes aging-related disease is by activating inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many of the problems associ...
Eligibility Criteria
Inclusion
- adults residing in a long term care facility
- resident for a minimum of four weeks prior to entry
- able to comply with study protocol
- able to follow simple instructions
- able to give informed consent or has a legally acceptable representative who is able to provide consent
Exclusion
- Age below 60 or above 80 years.
- Individuals at risk of hypotension or with symptomatic hypotension.
- Fasting hypoglycemia.
- Unstable diabetes
- Diabetics taking insulin
- 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 disorder
- Significant gastrointestinal disorder including inflammatory bowel disease but not constipation
- Significant kidney disorder
- Unstable or severe cardiac disease, recent MI or stroke either in past 6 months or significantly (i.e., severely) 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
- Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
- Intolerances or allergies to flax or vitamin D.
- Estimated probability of longevity of less than one year based on medical opinion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01234506
Start Date
October 1 2010
End Date
July 1 2013
Last Update
October 25 2018
Active Locations (1)
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1
Saskatoon Health Region
Saskatoon, Saskatchewan, Canada, S7K 5T6