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Clinical Trials/NCT01234506
NCT01234506
Completed
Phase 2

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

University of Saskatchewan1 site in 1 country21 target enrollmentOctober 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Oxidative Stress
Sponsor
University of Saskatchewan
Enrollment
21
Locations
1
Primary Endpoint
Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)
Status
Completed
Last Updated
7 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
July 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Whiting

PhD

University of Saskatchewan

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 24 weeks

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

Effect of SDG on oxidative stress and inflammation

Time Frame: 24 weeks

SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in oxidative stress measurements (plasma malondialdehyde), pro-inflammatory markers (IL-6, IL-1α, IL-1β, 8-isoprostane, TNF-α, C-reactive protein).

Secondary Outcomes

  • Effect of SDG supplement on blood levels of flax lignan metabolites(24 weeks)
  • To measure effects of SDG on bone resorption(24 weeks)
  • Effect of SDG on blood lipids(24 weeks)
  • Effect of SDG on quality of life(24 weeks)

Study Sites (1)

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