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Oxidative StressPhase 2Oxi-StressNCT01234506

Oxidative Stress and Nutritional Supplementation Intervention Study

A Phase 2 study testing secoisolariciresinol diglucoside in people with Oxidative Stress and Inflammation, run by University of Saskatchewan at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Oxidative Stress, Inflammation, Aging
What is being tested?
secoisolariciresinol diglucoside
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteCanada
Study dates
Oct 2010to Jul 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Saskatoon Health Region

    Saskatoon, Saskatchewan, S7K 5T6

Other trials in Canada

About this study

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

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.

Being tested
secoisolariciresinol diglucoside
Keywords
long term care, lignans, oxidative stress, inflammation, aging, dementia, postural balance, depression, muscle weakness, quality of life, pain
Medical subject headings
Inflammation, Dementia, Pain, Depression, Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • secoisolariciresinol diglucosideDietary supplement

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

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

Study groups in NCT01234506
Study groupRoleWhat they receive
secoisolariciresinol diglucosideActive comparatorSecoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care.
Receives: Dietary Supplement: secoisolariciresinol diglucoside
PlaceboPlacebo comparatorAn equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.
Receives: Dietary Supplement: secoisolariciresinol diglucoside

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 weeks

  2. 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).

    Measured: 24 weeks

Secondary outcomes (4)

  1. 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.

    Measured: 24 weeks

  2. 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.

    Measured: 24 weeks

  3. 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.

    Measured: 24 weeks

  4. 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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01234506
Sponsor's protocol ID
NHPD-150212
Acronym
Oxi-Stress
Status last verified
Oct 2018
First submitted
2 Nov 2010
Last updated
25 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20003621

  • 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.

    PubMed 28922068

  • 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.

    PubMed 28159728

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing secoisolariciresinol diglucoside in people with Oxidative Stress and Inflammation, run by University of Saskatchewan at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01234506, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.

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