Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

NCT02330276 | Completed Phase 1 Results DMC

• 2 other identifiers: 088471R01AT008310-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change From Baseline in Major Safety Endpoints

  Baseline and 24 hours

• Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)

  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

Study Arms (3)

10 mg (+)-epicatechin

EXPERIMENTAL

4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally

Drug: (+)-Epicatechin

30 mg (+)-epicatechin

EXPERIMENTAL

4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally

Drug: (+)-Epicatechin

100 mg (+)-epicatechin

EXPERIMENTAL

4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally

Drug: (+)-Epicatechin

Interventions

(+)-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.

Also known as: Epicatechin

10 mg (+)-epicatechin; 100 mg (+)-epicatechin; 30 mg (+)-epicatechin

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy or pre-diabetic based on medical history
• Male or female
• Must be 21 to 75 years of age (inclusive)
• Able to give informed consent to the procedures
• If female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. Women on estrogen therapy will be included.
• If of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
• Medication use stable for 4 weeks
• Body Mass Index (BMI) \> 27 kg/m\^2
• Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for diabetes

You may not qualify if:

• Type 2 diabetes
• Pregnancy
• Younger than 21 or older than 75 years of age
• Clinically significant abnormalities in liver or kidney function (\>3x ULN), determined in the last 6 months by a certified clinical laboratory
• Recent MI or stroke (within 6 months of screening)
• Blood pressure (BP) \>160 mmHg Systolic and \>100 mmHg Diastolic
• Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs
• Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• San Diego Veterans Healthcare System: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (1)

• 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.

  PMID: 39513382 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Catechin

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavonoids; Chromones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Robert R. Henry, MD
• Organization: Va San Diego Healthcare System

rrhenry@outlook.com

8585528585

Study Officials

• Robert R Henry, MD

  San Diego Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of Diabetes, Endocrinology and Metabolism

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 1, 2015
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)