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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT008310-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| San Diego Veterans Healthcare System | FED |
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Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.
This project is a double-blinded randomized Phase I study that will include dose-ranging one day PK and pharmacodynamic (PD) studies. Subjects will include healthy individuals and subjects who meet the American Diabetes Association (ADA) criteria for pre-diabetes, including IFG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg (+)-epicatechin | Experimental | 4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally |
|
| 30 mg (+)-epicatechin | Experimental | 4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally |
|
| 100 mg (+)-epicatechin | Experimental | 4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (+)-Epicatechin | Drug | The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites | This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers | Baseline and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Major Safety Endpoints | Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change), HR (10 bpm), creatinine (>1.5 ULN), and highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN). | Baseline and 24 hours |
| Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert R Henry, MD | San Diego Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39513382 | Derived | Yao Q, Wei T, Qiu H, Cai Y, Yuan L, Liu X, Li X. Epigenetic Effects of Natural Products in Inflammatory Diseases: Recent Findings. Phytother Res. 2025 Jan;39(1):90-137. doi: 10.1002/ptr.8364. Epub 2024 Nov 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 mg (+)-Epicatechin | 4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
| FG001 | 30 mg (+)-Epicatechin | 4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
| FG002 | 100 mg (+)-Epicatechin | 4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg (+)-Epicatechin | 4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites | This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers | Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | nM*hr | Baseline and 24 hours |
|
9 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 mg (+)-Epicatechin | 4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intermittent Headaches | Nervous system disorders | Headache | Non-systematic Assessment | Study subject reported having intermittent headaches (most likely due to lack of caffeine). Subject reported that the headaches resolved after taking the ibuprofen. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert R. Henry, MD | Va San Diego Healthcare System | 8585528585 | 3648 | rrhenry@outlook.com |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002392 | Catechin |
| ID | Term |
|---|---|
| D002839 | Chromans |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| University of California, San Diego |
| OTHER |
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|
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| Baseline and 24 hours |
| Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr) | Baseline and 24 hours |
| Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr) | Baseline and 24 hours |
| BG001 | 30 mg (+)-Epicatechin | 4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
| BG002 | 100 mg (+)-Epicatechin | 4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 30 mg (+)-Epicatechin | 4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
| OG002 | 100 mg (+)-Epicatechin | 4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. |
|
|
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| Secondary | Change From Baseline in Major Safety Endpoints | Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change), HR (10 bpm), creatinine (>1.5 ULN), and highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN). | Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method. | Posted | Number | participants | Baseline and 24 hours |
|
|
|
|
| Secondary | Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr) | Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | mg/dL*24hr | Baseline and 24 hours |
|
|
|
|
| Secondary | Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr) | Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | uU/mL*24 hr | Baseline and 24 hours |
|
|
|
|
| Secondary | Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr) | Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | ng/mL*24hr | Baseline and 24 hours |
|
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 30 mg (+)-Epicatechin | 4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. | 0 | 4 | 0 | 4 |
| EG002 | 100 mg (+)-Epicatechin | 4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally (+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included. | 0 | 4 | 1 | 4 |
|
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| D006571 |
| Heterocyclic Compounds |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |