Oxidative Stress and Nutritional Supplementation Intervention Study (Oxi-Stress)

University of Saskatchewan

Status and phase

Completed

Phase 2

Conditions

Aging

Inflammation

Oxidative Stress

Pain

Dementia

Treatments

Dietary Supplement: secoisolariciresinol diglucoside

Study type

Interventional

Funder types

Other

Identifiers

NCT01234506

NHPD-150212

Details and patient eligibility

About

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 associated with aging, including vascular dementia, Alzheimer's disease, osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome. Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein inducers decrease oxidative stress and associated inflammation. The flax lignan secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2 protein inducer. Animal and human studies have shown that consumption of flax seed or its component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of experimentally-induced cancers as well as metastases of human breast tumours implanted into nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and exerting control over cell differentiation. Adequate levels of vitamin D also appear to promote better glycemic control. The investigators predict that consumption of SDG in persons with adequate vitamin D status will decrease oxidative stress and associated inflammation. If this hypothesis is upheld, this research has the potential to greatly decrease healthcare costs while allowing healthier aging.

Enrollment

21 patients

Sex

All

Ages

60 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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