A Clinical Trial Investigating the Efficacy and Safety of a Lipase Thera-blend and a Lipase Thera… (NCT07020494) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Trial Investigating the Efficacy and Safety of a Lipase Thera-blend and a Lipase Thera-blend + Tributyrin on Memory in Healthy Adults With Self-reported Memory Problems
Canada90 participantsStarted 2025-08-25
Plain-language summary
The goal of this clinical trial is to investigate the efficacy and safety of Lipase Thera-blend and Lipase Thera-blend + tributyrin on memory in healthy adults with self-reported memory problems. The main question\[s\] it aims to answer \[is/are\]:
Does of Lipase Thera-blend improve memory in healthy adults? Does Lipase Thera-blend + tributyrin improve memory in healthy adults?
Researchers will compare Lipase Thera-blend and Lipase Thera-blend + tributyrin against a placebo to see if the investigational products improve memory parameters.
Participants will be asked to consume either placebo, Lipase Thera-blend, or Lipase Thera-blend + tributyrin and asked to complete memory questionnaires to assess memory.
Who can participate
Age range
30 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females between 30 and 79 years of age inclusive
. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
. Individuals with self-reported memory problems as assessed by a combination score of ≥ 6 on Everyday Memory Questionnaire (EMQ) questions 1, 2 and 18 at screening
. Absence of dementia or other significant cognitive impairment as assessed by Mini Mental State Examination - 2 Standard Version (MMSE-2) score ≥ 24
. Agrees to avoid high sources of caffeine (e.g., supplements, tea, coffee, energy drinks) and alcohol consumption for 24 hours prior to in-clinic visits
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The difference in change in spatial, working, and episodic/verbal memory
. Agrees to avoid first generation anti-allergy medication for 48 hours prior to in-clinic visits
. Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, smoking and sleep) as much as possible throughout the study
Exclusion criteria
. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients
. Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, stroke, neurodegenerative disease, infections, insomnia, depression, epileptic or other seizure-related disorders) that could interfere with study participation as assessed by the QI
. Self-reported color blindness/weakness as assessed by the QI
. Unstable metabolic disease or chronic diseases as assessed by the QI
. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)