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Dietary Supplement
Flax Beverage for Memory Issues
N/A
Waitlist Available
Led By Barry Campbell, MD
Research Sponsored by St. Boniface Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood collection takes 5 minutes. collection will take place at 2 time points, at a 3rd visit during baseline and at 6 months.
Summary
This trial will study whether flax beverage can improve memory in people with memory deficit, and whether this is linked to PET scan and blood biomarker results.
Who is the study for?
This trial is for individuals aged 60 to 84 with mild cognitive impairment (MCI) but not Alzheimer's or dementia. Participants must have normal thyroid function, be able to consent, and score within a specific range on cognitive tests. Excluded are those with recent bowel changes, certain psychiatric disorders, systemic cancer, severe blood pressure issues without stable treatment, and various medication restrictions.
What is being tested?
The study examines the impact of a flaxseed beverage on memory and cognition in people with MCI. It will also look at how brain imaging (PET scans) and blood markers correlate with memory performance. Participants will be compared to a control group receiving a placebo beverage.
What are the potential side effects?
While the trial description does not specify side effects of the flaxseed beverage intervention directly, potential general side effects may include digestive discomfort or allergic reactions for those sensitive to any components in the beverages.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the test takes 5 mins. testing will be done at 2 time points, that is at the 1st screening visit and at 6 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the test takes 5 mins. testing will be done at 2 time points, that is at the 1st screening visit and at 6 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cognitive/Memory score for CANTAB test.
Secondary study objectives
Aberrant Brain PET scans.
Blood draw.
Depression Anxiety and Stress Scale (DASS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental flax beverage groupExperimental Treatment1 Intervention
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.
Group II: Placebo control beverage groupPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
St. Boniface HospitalLead Sponsor
54 Previous Clinical Trials
15,015 Total Patients Enrolled
Pizzey IngredientsUNKNOWN
Canadian Agricultural PartnershipUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced sudden changes in your bowel movements for more than 2 weeks, unexplained bleeding from the rectum, or you have not been able to have a bowel movement even after using a laxative.You have taken medications called neuroleptics or narcotic painkillers within the last 4 weeks before screening.You have a serious neurological condition like Parkinson's disease, brain tumor, or multiple sclerosis.You have taken medications for Parkinson's disease, like Sinemet or amantadine, within the past two months.You have trouble swallowing food or liquids.You have not taken certain medications like beta-blockers, narcotics, methyldopa, or clonidine in the 4 weeks leading up to the screening.You have experienced hallucinations or have been diagnosed with schizophrenia in the past.You have taken strong medications called corticosteroids within the last 3 months.You have taken certain anti-seizure medications in the past 2 months.You have never taken any FDA-approved medications for Alzheimer's disease before.You have a history of alcohol or drug abuse, which was discovered during the evaluation process.You have taken long-acting medications for anxiety or sleep within the past 4 weeks.You have taken certain medications that can cause significant side effects on the nervous system or bladder within the past 4 weeks.You have stomach pain, feeling sick, throwing up, or a high body temperature.You have allergies to any of the ingredients in the test product or placebo.You are allergic to any of the ingredients in the product or you have lactose intolerance.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo control beverage group
- Group 2: Experimental flax beverage group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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