Oxidative StressPhase 1/2MODNCT01846117
Once-Daily Oral Dose of BeneFlax to Healthy Older Adults
A Phase 1/2 study testing secoisolariciresinol diglucoside, vitamin D in people with Oxidative Stress and Inflammation, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The investigators are investigating whether the flax lignan, secoisolariciresinol diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to be broken down in the body to produce the health benefits of flax. 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, vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Nov 2014
- Phase
- Phase 1/2
- 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
- Male or female adult 60 to 80 years residing in Saskatoon.
- Able to comply with study protocol.
- Able to follow simple instructions.
Who cannot join
- Age below 60 or above 80 years at initiation of the study.
- Individuals living in long term care homes.
- Individuals at risk of hypotension or with symptomatic hypotension.
- Fasting hypoglycemia.
- Unstable diabetes, or diabetics taking insulin (note: eligible diabetic participants will undergo additional testing during the study).
- Current cancer or diagnosed with cancer in the past 2 years.
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- Women with an immediate family history or personal history of breast cancer or ovarian cancer.
- Significant liver or other gastrointestinal disorder including inflammatory bowel disease. (While constipation is the most common gastrointestinal problem in the elderly, it would not be a contraindication)
- Significant kidney disorder.
- Unstable or severe cardiac disease, recent myocardial infarction or stroke (either in past 6 months or significantly 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 is allowed).
- Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
- Intolerances or allergies to flax or vitamin D.
- Allergy to whey
- Surgery within the last six months.
- Participation in any other clinical trial with an investigational agent within one month prior to randomization.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Saskatoon Centre for Patient-Oriented Research
Saskatoon, Saskatchewan, S7K 0M7
About this study
The investigators are investigating whether the flax lignan, secoisolariciresinol diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to be broken down in the body to produce the health benefits of flax. Flax lignan is separated from the whole flax seed as this compound is believed to have health effects. Decreasing oxidative stress and inflammation should improve a number of the problems associated with aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an equivalent amount of whey protein.
The investigators are comparing lignan to a placebo (whey powder) to examine whether a dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and inflammation.
- Conditions
- Oxidative Stress, Inflammation, Aging, Pain
- Being tested
- secoisolariciresinol diglucoside, vitamin D
- Keywords
- lignans, oxidative stress, inflammation, aging, muscle weakness, pain
- Medical subject headings
- Inflammation, Pain, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secoisolariciresinol diglucoside, vitamin DDietary supplement
Also called BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.
SDG supplementation as a packet of 1.6g/day of BeneFlax containing 600 mg SDG for 24 weeks Vitamin D Natural Product Number (NPN) 80003663 WN Pharmaceuticals Natural Factors Whey Factors
| Study group | Role | What they receive |
|---|---|---|
| secoisolariciresinol diglucoside | Active comparator | Secoisolariciresinol diglucoside (SDG) supplementation as 1.6g/day of BeneFlax containing 600 mg SDG. 1000 IU vitamin D as standard of care. Receives: Dietary Supplement: secoisolariciresinol diglucoside, vitamin D |
| Whey powder | Placebo comparator | Natural Factors Whey Factors whey protein (unflavored). An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care. Receives: Dietary Supplement: secoisolariciresinol diglucoside, vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of consumption of 600 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, 8, 16 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 (Aspartate transaminase (AST), Alanine Aminotransferase (ALT), Alkaline phosphatase (ALP), total protein, albumin, lipids, HbA1c (for diabetic participants). Blood pressure, pulse and respiratory rate will also be monitored at these time points.
Measured: 24 weeks
Secondary outcomes (5)
Effect of SDG on blood lipids
SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in nonfasting levels of cholesterol, LDL, HDL, and triglycerides.
Measured: 24 weeks
Effect of SDG on inflammation
SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in pro-inflammatory markers (Interleukin-6 (IL-6), IL-1α, IL-1β, 8-isoprostane, Tumor necrosis factor-α (TNF-α), C-reactive protein).
Measured: 24 weeks
Effect of SDG on quality of life
SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function.
Measured: 24 weeks
Effect of SDG supplement on blood levels of flax lignan metabolites
SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function.
Measured: 24 weeks
Effect of SDG supplement on fecal levels of flax lignan metabolites
To further understand the pharmacology of SDG, we will analyze fecal levels of the flax cyclolinopeptides. Levels will be determined 0 and 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Responsible party
- Sponsor
- Investigators
- Jennifer Jones, MD, FRCPC, Principal investigator, University of SaskatchewanJane Alcorn, DVD, PhD, Study chair, University of SaskatchewanSusan Whiting, PhD, Study chair, University of SaskatchewanKerry Mansell, BSP, PharmD, Study chair, University of SaskatchewanSharyle Fowler, MD, Study chair, University of SaskatchewanLilian Thorpe, MD, PhD, Study chair, University of SaskatchewanThomas Hadjistavropoulos, PhD, RD, Study chair, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846117
- Sponsor's protocol ID
- NHPD 186153
- Acronym
- MOD
- Status last verified
- Jun 2018
- First submitted
- 30 Apr 2013
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once-Daily Oral Dose of BeneFlax to Healthy Older Adults
- ClinicalTrials.gov ID
- NCT01846117
- Acronym / sponsor ID
- MOD / NHPD 186153
- Conditions
- Oxidative Stress, Inflammation, Aging, Pain
- Keywords
- lignans, oxidative stress, inflammation, aging, muscle weakness, pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are investigating whether the flax lignan, secoisolariciresinol diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to be broken down in the body to produce the health benefits of flax. Flax lignan is separated from the whole flax seed as this compound is believed to have health effects. Decreasing oxidative stress and inflammation should improve a number of the problems associated with aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an equivalent amount of whey protein.
The investigators are comparing lignan to a placebo (whey powder) to examine whether a dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| secoisolariciresinol diglucoside | Active comparator | Dietary Supplement: secoisolariciresinol diglucoside, vitamin DSecoisolariciresinol diglucoside (SDG) supplementation as 1.6g/day of BeneFlax containing 600 mg SDG. 1000 IU vitamin D as standard of care. |
| Whey powder | Placebo comparator | Dietary Supplement: secoisolariciresinol diglucoside, vitamin DNatural Factors Whey Factors whey protein (unflavored). An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adult 60 to 80 years residing in Saskatoon.
- Able to comply with study protocol.
- Able to follow simple instructions.
Key exclusion criteria (21 listed)
- Age below 60 or above 80 years at initiation of the study.
- Individuals living in long term care homes.
- Individuals at risk of hypotension or with symptomatic hypotension.
- Fasting hypoglycemia.
- Unstable diabetes, or diabetics taking insulin (note: eligible diabetic participants will undergo additional testing during the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| secoisolariciresinol diglucoside, vitamin DAlso: BeneFlax Flax Lignan Extract Archer Daniels Midland,#080001.SDG supplementation as a packet of 1.6g/day of BeneFlax containing 600 mg SDG for 24 weeks Vitamin D Natural Product Number (NPN) 80003663 WN Pharmaceuticals Natural Factors Whey Factors | Dietary supplement | Whey powder, secoisolariciresinol diglucoside |
Primary outcome
Safety of consumption of 600 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, 8, 16 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 (Aspartate transaminase (AST), Alanine Aminotransferase (ALT), Alkaline phosphatase (ALP), total protein, albumin, lipids, HbA1c (for diabetic participants). Blood pressure, pulse and respiratory rate will also be monitored at these time points.
5 secondary outcomes
Effect of SDG on blood lipids
Time frame: 24 weeks
Effect of SDG on inflammation
Time frame: 24 weeks
Effect of SDG on quality of life
Time frame: 24 weeks
Effect of SDG supplement on blood levels of flax lignan metabolites
Time frame: 24 weeks
Effect of SDG supplement on fecal levels of flax lignan metabolites
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Derived from this study: PubMed 28159728Alcorn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Jones, MD, FRCPC principal investigator
University of Saskatchewan
Jane Alcorn, DVD, PhD study chair
University of Saskatchewan
Susan Whiting, PhD study chair
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing secoisolariciresinol diglucoside, vitamin D 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 3 inclusion and 21 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 14 Jun 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 600 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y) (time frame: 24 weeks). 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 NCT01846117, which also lists 1 linked publication.
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 14 Jun 2018.