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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 | Clinical Trials | Clareo Health

RECRUITINGNA

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

A Randomized, Triple-blind, Placebo Controlled, Parallel 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

NCT07020494•Enzymedica

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - 79 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males and females between 30 and 79 years of age inclusive
•2. 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
•Or,
•Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
•* Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
•* Double-barrier method
•* Intrauterine devices
•* Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
•* Vasectomy of partner at least 6 months prior to screening
•* Abstinence and agrees to use contraception if planning on becoming sexually active during the study
+8 more criteria

Exclusion Criteria

•1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
•2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients
•3. 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
•4. Self-reported color blindness/weakness as assessed by the QI
•5. Unstable metabolic disease or chronic diseases as assessed by the QI
•6. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
•7. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
•8. Type I diabetes
•9. Type II diabetes if on insulin treatment. Type II diabetics on stable medication for at least three months and an HbA1c of \<8.0% may be included after assessment by the QI on a case-by-case basis
•10. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
+17 more criteria

Locations (1)

KGK Science Inc.

London, Ontario, Canada

Key Dates

Start Date

August 25, 2025

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

September 18, 2025

Enrollment

ESTIMATED participants

Conditions

Self-reported Memory ProblemsMemory

Interventions

Lipase Thera-blend

DIETARY_SUPPLEMENT

Lipase Thera-blend + tributyrin

DIETARY_SUPPLEMENT

Placebo

OTHER

Contacts

Erin Lewis, PhD

CONTACT

12262424551 elewis@kgkscience.com

David Crowley, MD

CONTACT

dcrowley@kgkscience.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

The Dynamics of Representational Change Underlying Recall

Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia

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