Diabetes Mellitus, Type 2Phase 2SODNCT01531569
Single Oral Dose of BeneFlax to Healthy Young and Older Adults
A Phase 2 study testing BeneFlax - 38% secoisolariciresinol diglucoside (SDG) in people with Diabetes Mellitus, Type 2 and Hypercholesterolemia, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This study is being done to look at age differences in the way the investigators bodies break down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is administered to research subjects in a product called BeneFlax, which a concentrated version of flax seed containing 38% SDG. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypercholesterolemia
- What is being tested?
- BeneFlax - 38% secoisolariciresinol diglucoside (SDG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Jun 2012
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults: 18-45 and 60-80 years of age
Who cannot join
- Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
- Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
- Individuals who smoke
- Individuals who have experienced diarrhea in the last three months
- Individuals who have taken oral antibiotics in the last three months
- Individuals who are currently taking warfarin or any of its derivatives
Show all 17Show fewer
- Individuals with low haemoglobin (<121g/L for women and <137g/L for men)
- Individuals with BMI under 19 or over 28
- Pregnant or lactating women
- Women with child bearing potential not using contraceptives
- Current diagnosis of a bleeding disorder or at risk of bleeding
- Individuals with gastrointestinal problems (such as ulcers), or convulsive, depressive, or hepatic disorders
- Individuals with diabetes mellitus
- Individuals currently taking a flax seed supplement
- Individuals with an allergy to flax seed
- Individuals who have donated blood or lost > 450 mL of blood within 56 days of study duration
- Individuals who have participated in any other clinical trial with and investigational agent within one month of starting this trial
Trial locations and contacts
1 site in 1 country.
Canada1 site
Saskatoon Centre for Patient Oriented Research - Saskatoon City Hospital
Saskatoon, Saskatchewan, S7K 0M7
About this study
Official title: Community Alliance for Quality of Life in Long Term Care: Single Oral Dose of BeneFlax to Healthy Young and Older Adults
This study is being done to look at age differences in the way the investigators bodies break down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is administered to research subjects in a product called BeneFlax, which a concentrated version of flax seed containing 38% SDG.
It is known that as people age, their bodies undergo physical changes both on the outside and the inside. The aging process may change the way that the investigators bodies deal with compounds the investigators eat. As an important measure of safety, the investigators want to check for evidence whether there is a difference in break down of SDG between different age groups.
- Conditions
- Diabetes Mellitus, Type 2, Hypercholesterolemia
- Being tested
- BeneFlax - 38% secoisolariciresinol diglucoside (SDG)
- Keywords
- Flaxseed, Lignans, Pharmacokinetics
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeneFlax - 38% secoisolariciresinol diglucoside (SDG)Other
Also called Secoisolariciresinol diglucoside (SDG)
0.8g of BeneFlax (contains 300mg SDG) given once by mouth
| Study group | Role | What they receive |
|---|---|---|
| BeneFlax | Experimental | BeneFlax given as a single oral dose to assess pharmacokinetics Receives: Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of secoisolariciresinol, enterodiol and enterolactone.
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Measured: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Time to reach peak plasma concentration (tmax) of secoisolariciresinol, enterodiol and enterolactone.
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Measured: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Area under the plasma concentration versus time curve (AUC) of secoisolariciresinol, enterodiol and enterolactone.
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Measured: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Elimination rate constant (k) of secoisolariciresinol, enterodiol and enterolactone.
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Measured: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Terminal phase half-life of secoisolariciresinol, enterodiol and enterolactone.
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Measured: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Secondary outcomes (3)
Food frequency questionnaire
Background information about participants usual dietary choices will be collected once prior to study commencement.
Measured: at 0 hours - prior to study commencement
Activity questionnaire
Background information about participants usual physical activities will be collected once prior to study commencement.
Measured: at 0 hours - prior to study commencement
Inflammatory markers
Measurement of the inflammatory markers interleukin-1a, interleukin-1b, interleukin-6 and TNF-a to determine participants baseline levels. The levels will only be tested once prior to study commencement
Measured: at 0 hours - prior to study commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Responsible party
- Principal investigator, Jane Alcorn, University of Saskatchewan
- Investigators
- Jane Alcorn, DVM, PhD, Principal investigator, College of Pharmacy & Nutrition, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531569
- Sponsor's protocol ID
- NHPD - 174041
- Acronym
- SOD
- Status last verified
- Oct 2016
- First submitted
- 9 Jan 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Alliance for Quality of Life in Long Term Care: Single Oral Dose of BeneFlax to Healthy Young and Older Adults
- ClinicalTrials.gov ID
- NCT01531569
- Acronym / sponsor ID
- SOD / NHPD - 174041
- Conditions
- Diabetes Mellitus, Type 2, Hypercholesterolemia
- Keywords
- Flaxseed, Lignans, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Feb 2012 (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.
This study is being done to look at age differences in the way the investigators bodies break down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is administered to research subjects in a product called BeneFlax, which a concentrated version of flax seed containing 38% SDG.
It is known that as people age, their bodies undergo physical changes both on the outside and the inside. The aging process may change the way that the investigators bodies deal with compounds the investigators eat. As an important measure of safety, the investigators want to check for evidence whether there is a difference in break down of SDG between different age groups.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BeneFlax | Experimental | Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)BeneFlax given as a single oral dose to assess pharmacokinetics |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults: 18-45 and 60-80 years of age
Key exclusion criteria (17 listed)
- Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
- Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
- Individuals who smoke
- Individuals who have experienced diarrhea in the last three months
- Individuals who have taken oral antibiotics in the last three months
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 |
|---|---|---|
| BeneFlax - 38% secoisolariciresinol diglucoside (SDG)Also: Secoisolariciresinol diglucoside (SDG)0.8g of BeneFlax (contains 300mg SDG) given once by mouth | Other | BeneFlax |
Primary outcome
Peak plasma concentration (Cmax) of secoisolariciresinol, enterodiol and enterolactone.
Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Time to reach peak plasma concentration (tmax) of secoisolariciresinol, enterodiol and enterolactone.
Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Area under the plasma concentration versus time curve (AUC) of secoisolariciresinol, enterodiol and enterolactone.
Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Elimination rate constant (k) of secoisolariciresinol, enterodiol and enterolactone.
Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Terminal phase half-life of secoisolariciresinol, enterodiol and enterolactone.
Time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
3 secondary outcomes
Food frequency questionnaire
Time frame: at 0 hours - prior to study commencement
Activity questionnaire
Time frame: at 0 hours - prior to study commencement
Inflammatory markers
Time frame: at 0 hours - prior to study commencement
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 26 Oct 2016.
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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.
Jane Alcorn, DVM, PhD principal investigator
College of Pharmacy & Nutrition, 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 2 study testing BeneFlax - 38% secoisolariciresinol diglucoside (SDG) in people with Diabetes Mellitus, Type 2 and Hypercholesterolemia, 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 1 inclusion and 17 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 26 Oct 2016. 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. 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?
Peak plasma concentration (Cmax) of secoisolariciresinol, enterodiol and enterolactone. (time frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2016.