Oxidative Stress and Nutritional Supplementation Intervention Study

Pain Clinical Trial

— Oxi-Stress  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234506
• Other study ID #: NHPD-150212
• Status: Completed
• Phase: Phase 2
• Start date: October 2010
• Est. completion date: July 2013

Study information

• Verified date: October 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Dementia
• Inflammation
• Oxidative Stress
• Pain

Intervention

Dietary Supplement:
• secoisolariciresinol diglucoside
SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks

Locations

Country	Name	City	State
Canada	Saskatoon Health Region	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Adolphe JL, Whiting SJ, Juurlink BH, Thorpe LU, Alcorn J. Health effects with consumption of the flax lignan secoisolariciresinol diglucoside. Br J Nutr. 2010 Apr;103(7):929-38. doi: 10.1017/S0007114509992753. Epub 2009 Dec 15. Review. — View Citation

Alcorn J, Whiting S, Viveky N, Di Y, Mansell K, Fowler S, Thorpe L, Almousa A, Cheng PC, Jones J, Billinsky J, Hadjistavropoulos T. Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults. JMIR Res — View Citation

Di Y, Jones J, Mansell K, Whiting S, Fowler S, Thorpe L, Billinsky J, Viveky N, Cheng PC, Almousa A, Hadjistavropoulos T, Alcorn J. Influence of Flaxseed Lignan Supplementation to Older Adults on Biochemical and Functional Outcome Measures of Inflammation — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)	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	24 weeks
Primary	Effect of SDG on oxidative stress and inflammation	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-1a, IL-1ß, 8-isoprostane, TNF-a, C-reactive protein).	24 weeks
Secondary	Effect of SDG on quality of life	SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in cognitive function, pain, and physical function including falls, as well as performance of activities of daily living.	24 weeks
Secondary	Effect of SDG supplement on blood levels of flax lignan metabolites	To further understand the pharmacology of SDG, we will analyze plasma levels of the SDG metabolites secoisolariciresinol, enterolactone and enterodiol in those subjects given flax lignan supplement. Levels will be determined 0, 12 and 24 weeks.	24 weeks
Secondary	To measure effects of SDG on bone resorption	SDG and placebo groups will be compared at 0 and 24 weeks for changes in bone resorption as assessed by measurement of cross-linked N-telopeptides type I collagen serum levels.	24 weeks
Secondary	Effect of SDG on blood lipids	SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in nonfasting levels of cholesterol, LDL, HDL, and triglycerides.	24 weeks