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

NCT07020494 | Completed

• 1 other identifier: 24EMCFA01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Self-reported Memory Problems; Memory

Keywords

Memory; Lipase; Enzyme; Therablend; Tributyrin

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Day 0 to 84

Secondary Outcomes (3)

• The difference in change in cognition, attention and learning

  Day 0 to 84

• The difference in change in gastrointestinal symptoms

  Day 0 to 84

• The difference in product perception

  Day 0 to 84

Other Outcomes (10)

• Incidence of post-emergent adverse events (AE)

  Day 0 to 84

• Clinically relevant changes in blood pressure after supplementation Indicating an adverse event

  Day 0 to 84

• Clinically relevant changes in heart rate after supplementation indicating an adverse event

  Day 0 to 84

Study Arms (3)

Lipase Thera-blend

EXPERIMENTAL

Lipase Thera-blend consists of lipase from Candida rugosa and lipase from Rhizopus oryzae

Dietary Supplement: Lipase Thera-blend

Lipase Thera-blend + tributyrin

EXPERIMENTAL

Lipase Thera-blend + tributyrin consists of tributyrin and lipase from Candida rugosa and lipase from Rhizopus oryzae.

Dietary Supplement: Lipase Thera-blend + tributyrin

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Lipase Thera-blend + tributyrin DIETARY_SUPPLEMENT

Participants will be instructed to consume take one capsule three times a day with food for the duration of the study period.

Lipase Thera-blend + tributyrin

Placebo OTHER

Participants will be instructed to consume take one capsule three times a day with food for the duration of the study period.

Placebo

Lipase Thera-blend DIETARY_SUPPLEMENT

Participants will be instructed to consume take one capsule three times a day with food for the duration of the study period.

Lipase Thera-blend

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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
• 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

You may not qualify if:

• 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)
• Type I diabetes
• 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
• 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
• History of or current diagnosis with kidney, pancreatic, and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Individuals with an autoimmune disease or are immune compromised

Sponsors & Collaborators

• Enzymedica: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location

MeSH Terms

Interventions

tributyrin

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: August 25, 2025
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CA (1)