Oxidative Stress and Nutritional Supplementation Intervention Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Oxidative Stress Inflammation Aging Dementia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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secoisolariciresinol diglucoside

Secoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care.

Group Type ACTIVE_COMPARATOR

secoisolariciresinol diglucoside

Intervention Type DIETARY_SUPPLEMENT

SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks

Placebo

An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.

Group Type PLACEBO_COMPARATOR

secoisolariciresinol diglucoside

Intervention Type DIETARY_SUPPLEMENT

SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks

Interventions

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secoisolariciresinol diglucoside

SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Beneflax Flax Lignan Extract Archer Daniels Midland,#080001. Natural Factors Whey Factors whey protein (unflavored). Vitamin D NPN 80003663 WN Pharmaceuticals

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes