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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Participants will be instructed to consume take one capsule three times a day with food for the duration of the study period.
Participants will be instructed to consume take one capsule three times a day with food for the duration of the study period.
Participants will be instructed to consume take one capsule three times a day with food for the duration of the study period.
KGK Science Inc.
London, Ontario, Canada
The difference in change in spatial, working, and episodic/verbal memory
The difference in change in spatial, working, and episodic/verbal memory as assessed by the Computerized Mental Performance Assessment System (COMPASS) between Lipase Thera-blend, Lipase Thera-blend + tributyrin and placebo from baseline at day 84. Scoring is not conducted on a scale.
Time frame: Day 0 to 84
The difference in change in change in memory
The difference in change in memory as measured by the Everyday Memory Questionnaire (EMQ) between Lipase Thera-blend, Lipase Thera-blend + tributyrin and placebo from baseline at day 84. Reporting is on a scale of 0 to 4, with 0 being "never" (good outcome) and 4 being "several times a day" (worse outcome).
Time frame: Day 0 to 84
The difference in change in cognition, attention and learning
The difference in change in cognition, attention and learning as assessed by the Computerized Mental Performance Assessment System (COMPASS) between Lipase Thera-blend, Lipase Thera-blend + tributyrin, and placebo from baseline at day 84
Time frame: Day 0 to 84
The difference in change in gastrointestinal symptoms
The difference in change in gastrointestinal symptoms, as assessed by Modified Gastrointestinal Symptom Rating Scale (GSRS) between Lipase Thera-blend, Lipase Thera-blend + tributyrin, and placebo from baseline at day 84. Reporting is on a scale of 0 to 3, with 0 being "no" (good outcome) and 3 being "continuous/frequent/daily" (worse outcome).
Time frame: Day 0 to 84
The difference in product perception
The difference in product perception, as assessed by the Product Perception Questionnaire (PPQ) between Lipase Thera-blend, Lipase Thera-blend + tributyrin, and placebo at day 84. Product perception is not scored on a scale.
Time frame: Day 0 to 84
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