Pre-diabetesPhase 1EpicatechinNCT02330276

Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

A Phase 1 study testing (+)-Epicatechin in people with Pre-diabetes, run by Veterans Medical Research Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin. Read more about this study

Who is it for?: Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Pre-diabetes
What is being tested?: (+)-Epicatechin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Aug 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA San Diego Healthcare System
San Diego, California, 92161

Other trials in United States

About this study

Official title: (+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

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

Read the detailed description

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.

Conditions: Pre-diabetes
Being tested: (+)-Epicatechin
Medical subject headings: Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

(+)-EpicatechinDrug
Also called 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.

Study groups in NCT02330276
Study group	Role	What they receive
10 mg (+)-epicatechin	Experimental	4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally Receives: Drug: (+)-Epicatechin
30 mg (+)-epicatechin	Experimental	4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally Receives: Drug: (+)-Epicatechin
100 mg (+)-epicatechin	Experimental	4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally Receives: Drug: (+)-Epicatechin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline and 24 hours

Secondary outcomes (4)

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).
Measured: Baseline and 24 hours
Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)
Measured: Baseline and 24 hours
Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)
Measured: Baseline and 24 hours
Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)
Measured: Baseline and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Aug 2015

First posted1 Jan 2015 (estimated)
Study startSep 2014
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pre-diabetesStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02330276
Sponsor's protocol ID: 08847
Other IDs: 1R01AT008310-01
Acronym: Epicatechin
Status last verified: Mar 2017
First submitted: 23 Dec 2014
Last updated: 17 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 39513382

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pre-diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: (+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
ClinicalTrials.gov ID: NCT02330276
Acronym / sponsor ID: Epicatechin / 08847
Conditions: Pre-diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Veterans Medical Research FoundationUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH), San Diego Veterans Healthcare System, University of California, San Diego
Study start: Sep 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 1 Jan 2015 (estimated)
Results: Posted 17 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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
10 mg (+)-epicatechin	Experimental	Drug: (+)-Epicatechin4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
30 mg (+)-epicatechin	Experimental	Drug: (+)-Epicatechin4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
100 mg (+)-epicatechin	Experimental	Drug: (+)-Epicatechin4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (8 listed)

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)

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
(+)-EpicatechinAlso: EpicatechinThe 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.	Drug	10 mg (+)-epicatechin, 100 mg (+)-epicatechin, 30 mg (+)-epicatechin

Primary outcome

Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
Time frame: Baseline and 24 hours
This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers

4 secondary outcomes

Change From Baseline in Major Safety Endpoints
Time frame: Baseline and 24 hours
Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)
Time frame: Baseline and 24 hours
Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)
Time frame: Baseline and 24 hours
Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)
Time frame: Baseline and 24 hours

Results and safety

Results posted to the registry on 17 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10 mg (+)-Epicatechin	4	4
30 mg (+)-Epicatechin	4	4
100 mg (+)-Epicatechin	4	4

Primary outcome: Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites

Time frame: Baseline and 24 hours. Mean (Standard Deviation). Unit: nM*hr

Measure	10 mg (+)-Epicatechin n = 4	30 mg (+)-Epicatechin n = 4	100 mg (+)-Epicatechin n = 4
Metabolites (AUC nM*hr)	105.8 (122.2)	132.7 (148.0)	162.3 (209.8)
epicatechin-sulfate (AUC nM*hr)	291.3 (119.2)	1639 (389.0)	3031 (1543)
epicatechin-glucuronide (AUC nM*hr)	3.375 (2.488)	47.18 (39.41)	398.3 (292.7)
Methyl-epi-sulfate (AUC nM*hr)	457.8 (211.5)	3190 (496.6)	16699 (7218)
Total parent compound and metabolites (AUC nM*hr)	840.3 (311.1)	4996 (570.0)	22563 (10335)

10 mg (+)-Epicatechin vs 30 mg (+)-Epicatechin vs 100 mg (+)-Epicatechin: p = 0.05, General linear mixed-effects models

Population analysed: Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 mg (+)-Epicatechin	0 of 4 (0%)	0 of 4 (0%)	Not reported
30 mg (+)-Epicatechin	0 of 4 (0%)	0 of 4 (0%)	Not reported
100 mg (+)-Epicatechin	0 of 4 (0%)	1 of 4 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39513382Yao 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.
Individual participant dataSharing planned: No

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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.

Robert R Henry, MD principal investigator

San Diego Veterans Healthcare System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing (+)-Epicatechin in people with Pre-diabetes, run by Veterans Medical Research Foundation at 1 site in United States.

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 9 inclusion and 8 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 17 Apr 2017. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites (time frame: Baseline and 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02330276, which also lists 1 linked publication.

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 17 Apr 2017.