Clinical Trial to Study the Effects of Dietary Flax Beverage on Memory and Cognition
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|ClinicalTrials.gov Identifier: NCT04645927|
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : June 30, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Memory; Disturbance, Mild||Dietary Supplement: flaxseed beverage Dietary Supplement: control beverage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-blinded, Randomized, Placebo-controlled Trial to Study the Effects of Dietary Flax Beverage on Memory and Cognition|
|Actual Study Start Date :||October 9, 2020|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||February 28, 2023|
Placebo Comparator: Placebo control beverage group
The placebo will be provided in the same unmarked plain packages and contain the same constituents, but without flax (control packages contain oat fiber and milk). For 180 days (6 months) participants will consume 2 servings of 330 ml of placebo beverage (i.e. normal fiber beverage; control) per day.
Dietary Supplement: control beverage
Oat fibre control. For 180 days (6 months) participants will consume 2 servings of 330 ml of placebo beverage (i.e. normal fiber beverage; control) per day.
Experimental: Experimental flax beverage group
Flax beverage (30 gr daily, oral) is presented in liquid form in plain unmarked packages. For 180 days (6 months) participants will consume 2 servings of 330 ml of flax beverage (treatment group; 30 gms flax/day beverage) per day.
Dietary Supplement: flaxseed beverage
Pizzey Ingredients Inc. introduced a flax beverage product that is a plant-based beverage product that is designed as an alternative to non-diary "milks" (almond milk & soy milk). Each 330 ml serving of flax beverage contains 15 g flaxseed, which amounts to 3.75 gm of omega-3 fatty acid. Preventing MCI or even AD may be within reach, if appropriate measures are taken early enough using strategies such as dietary supplementation.
- Cognitive/Memory score for CANTAB test. [ Time Frame: About 1.0 hour to administer. The memory test will be administered two times, that is before and after flax beverage dietary supplementation that lasts for 6 months; which will occur at baseline (2nd visit) at then 6 months later. ]Cambridge Neuropsychological Test Automated Battery (CANTAB). CANTAB, a test to assess neurocognitive performance. There is no cut-off score for the CANTAB test and this test is non-exclusionary.
- Memory test using the Montreal cognitive assessment (MoCA) instrument [ Time Frame: The test takes 15 mins. The test will be administered 2 times. First at the 1st visit or screening and then at the final visit 6 months later. ]MoCA is used as a screening tool to determine which participants are allowed to enter the trial. Participants will be included if their score ranges from 19-25 inclusive.
- Depression Anxiety and Stress Scale (DASS) [ Time Frame: The test takes 5 mins. Testing will be done at 2 time points, that is at the 1st screening visit and at 6 months. ]The DASS is a suitable instrument to screen for depressive disorders. A score of Severe or Extremely Severe for any of the 3 DASS measurements (Depression, Anxiety or Stress) will exclude the participant from the study.
- Aberrant Brain PET scans. [ Time Frame: One and one-half hours for each PET scan. The PET scans will be administered two times, which will occur at baseline (3rd visit) at then 6 months later. ]A subset of participants randomly selected will have a brain PET scan. Since a limited number of participants will have PET scan (10 flax beverage group, 10 control beverage group, n=20).
- Blood draw. [ Time Frame: Blood collection takes 5 minutes. Collection will take place at 2 time points, at a 3rd visit during baseline and at 6 months. ]Blood (16 ml) will be collected from each participant.
- Blood pressure measurement. [ Time Frame: Blood pressure measurements take 5 minutes. Blood pressure measurements will occur two times, which will occur at baseline - 2nd visit and then 6 months later. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||60 Years to 84 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Normal thyroid function (as determined by case history).
- Patients must have MCI or Minor Neurocognitive Disorder according to DSM-5 (see definition of DSM-5 under List of Abbreviations on Page 5).
- Ability to provide written informed consent.
- Age 60 to 84.
- Any diagnosis of Alzheimer's Disease (AD) or Dementia by a physician.
- MoCA Cognitive Test Score outside 19-25 inclusive (determined in first Baseline Visit).
- DASS Test Score: Severe or Extremely Severe Score for any of the 3 measurements (Depression, Anxiety or Stress) (determined in the first Baseline Visit).
- Allergies to any of the components of the Test Product or Placebo (see Section 7.5).
- Lactose Intolerance or Allergy to any of the product components.
- Vitamin E, Vitamin B (any form), fish oil, omega pills or flaxseed products.
- Any significant neurological disease as determined during screening (case history). Examples include Parkinson's, Huntington's, brain tumor, seizure disorders, subdural hematoma, multiple sclerosis, history of head trauma including multiple head trauma with loss of consciousness.
- Diagnosis of diabetes mellitus as determined during screening (case history).
- Significant cerebrovascular or cardiovascular disease as determined during screening (case history).
- Psychotic features or history of schizophrenia as determined during screening (case history).
- Another major psychiatric disorder as described in DSM 5 within the past 2 years (see definition of DSM 5 as described under List of Abbreviations on Page 5).
- History of alcohol or substance abuse as determined during screening (case history).
- History of systemic cancer as determined during screening (case history).
- Sudden changes in bowel movements for more than 2 weeks, undiagnosed rectal bleeding, or failure to defecate following the use of a laxative.
- Presence of abdominal pain, nausea, vomiting or fever.
- Difficulty in swallowing (dysphagia).
- Blood Pressure (systolic >180 and/or diastolic >110). A stable dose of hypertension drugs for elevated blood pressure during the course of the study is not exclusionary.
- Non AD Medications: Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening.
- Use of anti-Parkinsonian medications (e.g. Sinemet, amantadine, bromocriptine, pergolide & selegiline) within 2 months prior to screening.
- Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening.
- Use of long-acting benzodiazepines or barbiturates within 4 weeks prior to screening.
- Use of short-acting anxiolytics or sedative hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of screening).
- Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable).
- Use of systemic corticosteroids within 3 months prior to screening.
- Medications with significant cholinergic or anticholinergic side effects (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to screening.
- Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine) within 2 months prior to screening.
- Use of warfarin (Coumadin) within 4 weeks prior to screening.
- Any prior use of any FDA approved medications for the treatment of Alzheimer's disease (e.g. tacrine, donepezil, or other newly approved medications).
- Other: Subjects who, in the PI's opinion, will not comply with study procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645927
|Contact: Nancy Olson, BScfirstname.lastname@example.org|
|Contact: Benedict C Albensi, PhDemail@example.com|
|I.H. Asper Clinical Research Institute||Recruiting|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Contact: Nancy Olson, BSc 204-235-3941 firstname.lastname@example.org|
|Contact: Aida Adlimoghaddam, PhD 204-235-3941 email@example.com|
|Principal Investigator: Benedict C Albensi, PhD, BCMAS, CRQM|
|Health Sciences Ctr.||Recruiting|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Contact: Nancy Olson 204-235-3941 firstname.lastname@example.org|
|Principal Investigator:||Barry Campbell, MD||St. Boniface Hospital|
|Responsible Party:||Dr. Benedict C. Albensi, Principal Investigator and Professor, St. Boniface Hospital|
|Other Study ID Numbers:||
|First Posted:||November 27, 2020 Key Record Dates|
|Last Update Posted:||June 30, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|