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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01234506
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
Saskatchewan Health Research Foundation
Information provided by (Responsible Party):
Susan Whiting, University of Saskatchewan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Inflammation Aging Dementia Pain Dietary Supplement: secoisolariciresinol diglucoside Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Community Alliance for Quality of Life in Long Term Care: Oxidative Stress and Nutritional Supplementation Intervention Study
Study Start Date : October 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: secoisolariciresinol diglucoside
Secoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care.
 Dietary Supplement: secoisolariciresinol diglucoside
SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks
Other Names:
  • Beneflax Flax Lignan Extract Archer Daniels Midland,#080001.
  • Natural Factors Whey Factors whey protein (unflavored).
  • Vitamin D NPN 80003663 WN Pharmaceuticals
Placebo Comparator: Placebo
An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.
 Dietary Supplement: secoisolariciresinol diglucoside
SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks
Other Names:
  • Beneflax Flax Lignan Extract Archer Daniels Midland,#080001.
  • Natural Factors Whey Factors whey protein (unflavored).
  • Vitamin D NPN 80003663 WN Pharmaceuticals


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Effect of SDG on quality of life [ Time Frame: 24 weeks ]
    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.

  2. Effect of SDG supplement on blood levels of flax lignan metabolites [ Time Frame: 24 weeks ]
    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.

  3. To measure effects of SDG on bone resorption [ Time Frame: 24 weeks ]
    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.

  4. Effect of SDG on blood lipids [ Time Frame: 24 weeks ]
    SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in nonfasting levels of cholesterol, LDL, HDL, and triglycerides.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234506


Locations
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Canada, Saskatchewan
Saskatoon Health Region
Saskatoon, Saskatchewan, Canada, S7K 5T6
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Health Research Foundation
Investigators
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Principal Investigator: Susan J Whiting, PhD University of Saskatchewan
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Susan Whiting, PhD, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01234506    
Other Study ID Numbers: NHPD-150212
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Keywords provided by Susan Whiting, University of Saskatchewan:
long term care
lignans
oxidative stress
inflammation
aging
dementia
 postural balance
depression
muscle weakness
quality of life
pain
Additional relevant MeSH terms:
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Dementia
Inflammation
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Vitamin D
Secoisolariciresinol
 Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists