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Trial record 6 of 84 for:    catechin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02330276
Recruitment Status : Completed
First Posted : January 1, 2015
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
San Diego Veterans Healthcare System
University of California, San Diego
Information provided by (Responsible Party):
Robert R. Henry, MD, Veterans Medical Research Foundation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pre-diabetes
Intervention Drug: (+)-Epicatechin
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 4 4 4
Completed 4 4 4
Not Completed 0 0 0
Arm/Group Title 10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin Total
Hide Arm/Group Description

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  75.0%
4
 100.0%
0
   0.0%
7
  58.3%
>=65 years
1
  25.0%
0
   0.0%
4
 100.0%
5
  41.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 12 participants
Female
1
  25.0%
2
  50.0%
1
  25.0%
4
  33.3%
Male
3
  75.0%
2
  50.0%
3
  75.0%
8
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 12 participants
American Indian or Alaska Native
1
  25.0%
0
   0.0%
0
   0.0%
1
   8.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  75.0%
0
   0.0%
0
   0.0%
3
  25.0%
White
0
   0.0%
4
 100.0%
4
 100.0%
8
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 4 participants 12 participants
4 4 4 12
1.Primary Outcome
Title Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
Hide Description This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers
Time Frame Baseline and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
Arm/Group Title 10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 4 4 4
Mean (Standard Deviation)
Unit of Measure: nM*hr
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg (+)-Epicatechin, 30 mg (+)-Epicatechin, 100 mg (+)-Epicatechin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments The reported P-Value was calculated
Method General linear mixed-effects models
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Major Safety Endpoints
Hide Description 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).
Time Frame Baseline and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
Arm/Group Title 10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 4 4 4
Measure Type: Number
Unit of Measure: participants
0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg (+)-Epicatechin, 30 mg (+)-Epicatechin, 100 mg (+)-Epicatechin
Comments Primary hypothesis: None of the doses of (+)-epicatechin will differ with regard to change from baseline in any of the major safety endpoints; heart rate, systolic and diastolic blood pressure.
Type of Statistical Test Other
Comments one way ANOVA between groups
Statistical Test of Hypothesis P-Value <0.05
Comments for change in heart rate at 24 hr post-dosing from baseline between the 3 doses
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 77.9
Confidence Interval (2-Sided) 95%
70.3 to 85.5
Parameter Dispersion
Type: Standard Deviation
Value: 11.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)
Hide Description [Not Specified]
Time Frame Baseline and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
Arm/Group Title 10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 4 4 4
Mean (Standard Deviation)
Unit of Measure: mg/dL*24hr
368.3  (158.5) 342.6  (193.5) 513.4  (185.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg (+)-Epicatechin, 30 mg (+)-Epicatechin, 100 mg (+)-Epicatechin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments The reported P-Value was calculated
Method General linear mixed-effects models
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)
Hide Description [Not Specified]
Time Frame Baseline and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
Arm/Group Title 10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 4 4 4
Mean (Standard Deviation)
Unit of Measure: uU/mL*24 hr
1192  (488.5) 707.2  (211.5) 1334  (666.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg (+)-Epicatechin, 30 mg (+)-Epicatechin, 100 mg (+)-Epicatechin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments The reported P-Value was calculated
Method General linear mixed-effects models
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)
Hide Description [Not Specified]
Time Frame Baseline and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
Arm/Group Title 10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 4 4 4
Mean (Standard Deviation)
Unit of Measure: ng/mL*24hr
61.74  (27.64) 57.56  (28.56) 64.23  (27.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg (+)-Epicatechin, 30 mg (+)-Epicatechin, 100 mg (+)-Epicatechin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments The reported P-Value was calculated
Method General linear mixed-effects models
Comments [Not Specified]
Time Frame 9 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
10 mg (+)-Epicatechin 30 mg (+)-Epicatechin 100 mg (+)-Epicatechin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      1/4 (25.00%)    
Nervous system disorders       
Intermittent Headaches * 1 [1]  0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Headache
[1]
Study subject reported having intermittent headaches (most likely due to lack of caffeine). Subject reported that the headaches resolved after taking the ibuprofen.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Robert R. Henry, MD
Organization: Va San Diego Healthcare System
Phone: 8585528585 ext 3648
Responsible Party: Robert R. Henry, MD, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02330276     History of Changes
Other Study ID Numbers: 08847
1R01AT008310-01 ( U.S. NIH Grant/Contract )
First Submitted: December 23, 2014
First Posted: January 1, 2015
Results First Submitted: January 8, 2016
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017