Once-Daily Oral Dose of BeneFlax to Healthy Older Adults

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.