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Trial record 7 of 13 for:    oxi

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

Tracking Information
First Submitted Date  ICMJE November 2, 2010
First Posted Date  ICMJE November 4, 2010
Last Update Posted Date October 25, 2018
Study Start Date  ICMJE October 2010
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2010)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2010)
  • 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.
  • 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.
  • 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.
  • 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 triglyciderides.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxidative Stress and Nutritional Supplementation Intervention Study
Official Title  ICMJE Community Alliance for Quality of Life in Long Term Care: Oxidative Stress and Nutritional Supplementation Intervention Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Oxidative Stress
  • Inflammation
  • Aging
  • Dementia
  • Pain
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: secoisolariciresinol diglucoside
  • Placebo Comparator: Placebo
    An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.
    Intervention: Dietary Supplement: secoisolariciresinol diglucoside
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2013)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2010)
154
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01234506
Other Study ID Numbers  ICMJE NHPD-150212
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Whiting, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Saskatchewan Health Research Foundation
Investigators  ICMJE
Principal Investigator: Susan J Whiting, PhD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP