Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04645927 |
Other study ID # |
CT/2019/004 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 9, 2020 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
August 2023 |
Source |
St. Boniface Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Investigate the effects of flax beverage consumption on memory and cognition in subjects with
memory deficit (i.e., amnestic MCI). In addition, it will correlate PET scan results (for a
limited number of participants) and blood biomarker data with memory test results.
Description:
This study is a multisite, double-blinded, randomized, placebo-controlled trial to examine
the effect of daily flax beverage consumption on memory and cognition. This trial will be
conducted at the I.H. Asper Clinical Research Institute and at the John Buhler Research
Centre, Health Sciences Centre in Winnipeg, Manitoba.
Sixty men and women diagnosed with mild cognitive impairment (MCI) aged 60 to 84 years will
be recruited by using advertisements/flyers, radio/TV announcements, the Alzheimer's Society
network and/or will be referred by a general practitioner. The participants will be randomly
divided: 30 subjects in the flax-treatment group and 30 placed in the control - placebo
group. For 180 days (6 months) participants will either consume 2 servings of 330 ml of flax
beverage (treatment group; 30 gms flax/day beverage) or placebo beverage (i.e. normal fiber
beverage; control) per day.
Potential candidates will first be screened in-person at the I.H. Asper Clinical Research
Institute; the screening visit (SV1) will last about 2 hours. The subject will first be asked
to read, understand and sign a consent form. Then they will be subject to a questionnaire, a
medical history, a blood pressure (BP) measurement and 2 screening memory & cognition tests;
Montreal Cognitive Assessment (MoCA), which is sensitive to MCI and the Depression Anxiety
Stress Scale (DASS). Based on this initial in-person visit, investigators will determine
participants' eligibility to continue in the study. Study staff will contact the Office of
Clinical Research at St. Boniface Hospital to assign an eligible participant a unique study
code.
If the participant meets the inclusion criteria based on their SV1 visit, investigators will
plan a baseline visit for the participant. During the first baseline visit (BV1), if the
subject is interested to take part in this study, they will be asked to perform the Cambridge
Neuropsychological Test Automated Battery (CANTAB). This baseline visit will take about 1.0
hours to accomplish.
Investigators will then plan a second baseline visit (BV2) for a fasting blood draw, which
will take approximately 15 minutes to complete. The participant will have to fast for 10
hours prior to their visit and a certified phlebotomist will collect approximately 16 mL of
blood (about 3 teaspoons). In addition, investigators will review beverage consumption logs
with participants and provide 30 days of beverage regime if they have a vehicle to take it
home (if they have a car and are not scheduled for a PET scan).
A third baseline visit will be scheduled (BV3), where some participants will be randomly
invited for a brain PET scan (10 controls from the placebo group and 10 from Flax-treatment
group) at the baseline and at the end of the study. For this procedure the participant will
need to fast for 4 hours. The participants have the option of declining the PET scans, if
they wish.
The participants will need to be provided with 30 days of flax beverage every month (by
either pickup or delivery). They also will need to submit their consumption log sheets
(requested monthly) at this time to be reviewed by a study coordinator.
At the end of the study, the participants (T180) will have final follow up review of their
medical history, blood pressure measurements and memory and cognitive tests (similar to those
performed at the screening visit and baseline visit 1), along with a fasting blood draw (FV1,
FV2). In addition, a third final study visit (FV3) will be scheduled for those who agreed to
brain PET scans at the beginning of the study. In the final visit, an honorarium of $25.00
will be paid for their participation.
Each participant will visit the I.H Asper Clinical Research Institute a minimum of 5 times
for the entire study. Those participants selected for brain PET scan will have 2 additional
visits at John Buhler Research Centre, Health Sciences Centre; therefore, they will need a
total of 7 visits for the entire study.