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

Primary Purpose

Oxidative Stress, Inflammation, Aging

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
secoisolariciresinol diglucoside
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxidative Stress focused on measuring long term care, lignans, oxidative stress, inflammation, aging, dementia, postural balance, depression, muscle weakness, quality of life, pain

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saskatoon Health Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

secoisolariciresinol diglucoside

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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-1α, IL-1β, 8-isoprostane, TNF-α, C-reactive protein).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 2, 2010
Last Updated
October 23, 2018
Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01234506
Brief Title
Oxidative Stress and Nutritional Supplementation Intervention Study
Acronym
Oxi-Stress
Official Title
Community Alliance for Quality of Life in Long Term Care: Oxidative Stress and Nutritional Supplementation Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation, Aging, Dementia, Pain
Keywords
long term care, lignans, oxidative stress, inflammation, aging, dementia, postural balance, depression, muscle weakness, quality of life, pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
secoisolariciresinol diglucoside
Arm Type
Active Comparator
Arm Description
Secoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.
Intervention Type
Dietary Supplement
Intervention Name(s)
secoisolariciresinol diglucoside
Other Intervention Name(s)
Beneflax Flax Lignan Extract Archer Daniels Midland,#080001., Natural Factors Whey Factors whey protein (unflavored)., Vitamin D NPN 80003663 WN Pharmaceuticals
Intervention Description
SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks
Primary Outcome Measure Information:
Title
Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)
Description
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
Time Frame
24 weeks
Title
Effect of SDG on oxidative stress and inflammation
Description
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).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Effect of SDG on quality of life
Description
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.
Time Frame
24 weeks
Title
Effect of SDG supplement on blood levels of flax lignan metabolites
Description
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.
Time Frame
24 weeks
Title
To measure effects of SDG on bone resorption
Description
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.
Time Frame
24 weeks
Title
Effect of SDG on blood lipids
Description
SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in nonfasting levels of cholesterol, LDL, HDL, and triglycerides.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J Whiting, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saskatoon Health Region
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 5T6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20003621
Citation
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.
Results Reference
background
PubMed Identifier
28922068
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. J Am Coll Nutr. 2017 Nov-Dec;36(8):646-653. doi: 10.1080/07315724.2017.1342213. Epub 2017 Sep 18.
Results Reference
result
PubMed Identifier
28159728
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 Protoc. 2017 Feb 3;6(2):e14. doi: 10.2196/resprot.6817.
Results Reference
result

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Oxidative Stress and Nutritional Supplementation Intervention Study

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