Clinical trial · Interventional
Clinical Trial to Study the Effects of Dietary Flax Beverage on Memory and Cognition
A Double-blinded, Randomized, Placebo-controlled Trial to Study the Effects of Dietary Flax Beverage on Memory and Cognition
NCT04645927CI-TRIAL-00090494completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Memory; Disturbance, Mild | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| control beverage | Dietary Supplement | — | UNRESOLVED |
| flaxseed beverage | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo control beverage group
- description
- 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.
- interventionNames
- Dietary Supplement: control beverage
- type
- EXPERIMENTAL
- label
- Experimental flax beverage group
- description
- 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.
- interventionNames
- Dietary Supplement: flaxseed beverage
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 84 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.