Clinical Trial to Study the Effects of Dietary Flax Beverage on Memory and Cognition

NCT04645927 | Completed DMC

• 1 other identifier: CT/2019/004
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Memory; Disturbance, Mild

Outcome Measures

Primary Outcomes (1)

• Cognitive/Memory score for CANTAB test.

  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.

  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.

Secondary Outcomes (5)

• Memory test using the Montreal cognitive assessment (MoCA) instrument

  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.

• Depression Anxiety and Stress Scale (DASS)

  The test takes 5 mins. Testing will be done at 2 time points, that is at the 1st screening visit and at 6 months.

• Aberrant Brain PET scans.

  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.

• Blood draw.

  Blood collection takes 5 minutes. Collection will take place at 2 time points, at a 3rd visit during baseline and at 6 months.

• Blood pressure measurement.

  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.

Study Arms (2)

Placebo control beverage group

PLACEBO COMPARATOR

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

Experimental flax beverage group

EXPERIMENTAL

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

Interventions

flaxseed beverage DIETARY_SUPPLEMENT

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.

Experimental flax beverage group

control beverage DIETARY_SUPPLEMENT

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.

Placebo control beverage group

Eligibility Criteria

• Age: 60 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Boniface Hospital: lead
• Pizzey Ingredients: collaborator
• Canadian Agricultural Partnership: collaborator

Study Sites (2)

I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Sciences Ctr.

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Barry Campbell, MD

  St. Boniface Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 27, 2020
• Study Start: October 9, 2020
• Primary Completion: September 21, 2023
• Study Completion: December 19, 2023
• Last Updated: June 3, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)