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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipase Thera-blend | Experimental | Lipase Thera-blend consists of lipase from Candida rugosa and lipase from Rhizopus oryzae |
|
| Lipase Thera-blend + tributyrin | Experimental | Lipase Thera-blend + tributyrin consists of tributyrin and lipase from Candida rugosa and lipase from Rhizopus oryzae. |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 to 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Day 0 to 84 |
| Clinically relevant changes in blood pressure after supplementation Indicating an adverse event |
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
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
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6B3L1 | Canada |
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| 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. |
|
| Placebo | Other | Participants will be instructed to consume take one capsule three times a day with food for the duration of the study period. |
|
| 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). |
| 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. | 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 | Clinically relevant changes in heart rate after supplementation indicating an adverse event | Day 0 to 84 |
| Clinically relevant changes in aspartate aminotransferase (AST) after supplementation indicating an adverse event | Clinically relevant changes in aspartate aminotransferase (AST) after supplementation indicating an adverse event | Day 0 to 84 |
| Clinically relevant changes in alanine aminotransferase (ALT) after supplementation indicating an adverse event | Clinically relevant changes in alanine aminotransferase (ALT) after supplementation indicating an adverse event | Day 0 to 84 |
| Clinically relevant changes in alkaline phosphatase (ALP) after supplementation indicating an adverse event | Clinically relevant changes in alkaline phosphatase (ALP) after supplementation indicating an adverse event | Day 0 to 84 |
| Clinically relevant changes in total bilirubin after supplementation indicating an adverse event | Clinically relevant changes in total bilirubin after supplementation indicating an adverse event | Day 0 to 84 |
| Clinically relevant changes in creatinine after supplementation indicating an adverse event | Clinically relevant changes in creatinine after supplementation indicating an adverse event | Day 0 to 84 |
| Clinically relevant changes in electrolytes (Na, K, Cl) after supplementation indicating an adverse event | Clinically relevant changes in electrolytes (Na, K, Cl) after supplementation indicating an adverse event | Day 0 to 84 |
| Clinically relevant changes in estimated glomerular filtration rate (eGFR)) after supplementation indicating an adverse event | Clinically relevant changes in estimated glomerular filtration rate (eGFR)) after supplementation indicating an adverse event | Day 0 to 84 |
| ID | Term |
|---|---|
| C005830 | tributyrin |
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