Self-reported Memory ProblemsNCT07020494
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 study testing Lipase Thera-blend and Lipase Thera-blend + tributyrin in people with Self-reported Memory Problems and Memory, run by Enzymedica at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-reported Memory Problems, Memory
- What is being tested?
- Lipase Thera-blend and Lipase Thera-blend + tributyrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2025to 13 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, smoking and sleep) as much as possible throughout the study
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI)
Who cannot join
- 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
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- 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
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Use of medical cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Sections 7.3.1 and 7.3.2)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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?
Read more
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
- Being tested
- Lipase Thera-blend, Lipase Thera-blend + tributyrin, Placebo
- Keywords
- Memory, Lipase, Enzyme, Therablend, Tributyrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipase Thera-blendDietary 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 + tributyrinDietary supplement
Participants will be instructed to consume take one capsule three times a day with food for the duration of the study period.
PlaceboOther
Participants will be instructed to consume take one capsule three times a day with food for the duration of the study period.
| Study group | Role | What they receive |
|---|---|---|
| Lipase Thera-blend | Experimental | Lipase Thera-blend consists of lipase from Candida rugosa and lipase from Rhizopus oryzae Receives: 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. Receives: Dietary Supplement: Lipase Thera-blend + tributyrin |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day 0 to 84
Secondary outcomes (3)
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
Measured: 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).
Measured: 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.
Measured: Day 0 to 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start25 Aug 2025
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-reported Memory ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020494
- Sponsor's protocol ID
- 24EMCFA01
- Status last verified
- Mar 2026
- First submitted
- 26 May 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07020494
- Acronym / sponsor ID
- 24EMCFA01
- Conditions
- Self-reported Memory Problems, Memory
- Keywords
- Memory, Lipase, Enzyme, Therablend, Tributyrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- EnzymedicaIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lipase Thera-blend | Experimental | Dietary Supplement: Lipase Thera-blendLipase Thera-blend consists of lipase from Candida rugosa and lipase from Rhizopus oryzae |
| Lipase Thera-blend + tributyrin | Experimental | Dietary Supplement: Lipase Thera-blend + tributyrinLipase Thera-blend + tributyrin consists of tributyrin and lipase from Candida rugosa and lipase from Rhizopus oryzae. |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipase Thera-blendParticipants will be instructed to consume take one capsule three times a day with food for the duration of the study period. | Dietary supplement | Lipase Thera-blend |
| Lipase Thera-blend + tributyrinParticipants will be instructed to consume take one capsule three times a day with food for the duration of the study period. | Dietary supplement | Lipase Thera-blend + tributyrin |
| PlaceboParticipants will be instructed to consume take one capsule three times a day with food for the duration of the study period. | Other | Placebo |
Primary outcome
The difference in change in spatial, working, and episodic/verbal memory
Time frame: Day 0 to 84
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.
The difference in change in change in memory
Time frame: Day 0 to 84
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).
3 secondary outcomes
The difference in change in cognition, attention and learning
Time frame: Day 0 to 84
The difference in change in gastrointestinal symptoms
Time frame: Day 0 to 84
The difference in product perception
Time frame: Day 0 to 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipase Thera-blend and Lipase Thera-blend + tributyrin in people with Self-reported Memory Problems and Memory, run by Enzymedica at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change in spatial, working, and episodic/verbal memory (time frame: Day 0 to 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.