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Community Alliance for Quality of Life in Long Term Care: Oxidative Stress and Nutritional Supplementation Intervention Study

Phase 2
60 Years
80 Years
Open (Enrolling)
Oxidative Stress, Inflammation, Aging, Dementia, Pain

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Trial Information

Community Alliance for Quality of Life in Long Term Care: Oxidative Stress and Nutritional Supplementation Intervention Study

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)

Outcome Description:

Adverse event occurrences will be compared descriptively between the SDG and placebo groups. Safety will be assessed at 0, 6, 12, 18 and 24 weeks; as part of the blood collection (urea, creatinine, total bilirubin, platelets, hematocrit, haemoglobin, mean corpuscular haemoglobin, mean corpuscular volume, white blood cell count, total protein including albumin and prealbumin, total calcium, electrolytes, glucose, liver enzymes (AST, ALT, ALP), total protein, albumin, lipids, HbA1c (for diabetic participants). Blood pressure measurements will be performed every two weeks

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Susan J Whiting, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Saskatchewan


Canada: Health Canada

Study ID:




Start Date:

October 2010

Completion Date:

June 2013

Related Keywords:

  • Oxidative Stress
  • Inflammation
  • Aging
  • Dementia
  • Pain
  • long term care
  • lignans
  • oxidative stress
  • inflammation
  • aging
  • dementia
  • postural balance
  • depression
  • muscle weakness
  • quality of life
  • pain
  • Dementia
  • Inflammation