Trial Outcomes & Findings for Effects of Epicatechin on Statins for Mitochondrial Dysfunction and Impaired Exercise Capacity (NCT NCT02490527)
NCT ID: NCT02490527
Last Updated: 2026-07-31
Results Overview
Cardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2026-07-31
Participant Flow
Participant milestones
| Measure |
Statin Only
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
Placebo: A substance that has no therapeutic effect and will act as a control.
|
Statin and Epicatechin
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
Pure epicatechin capsules (50mg): Epicatechin is a compound found naturally in dark chocolate.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
|
|---|---|---|
|
Cohort 1
STARTED
|
3
|
3
|
|
Cohort 1
COMPLETED
|
3
|
3
|
|
Cohort 1
NOT COMPLETED
|
0
|
0
|
|
Cohort 2
STARTED
|
5
|
8
|
|
Cohort 2
COMPLETED
|
5
|
8
|
|
Cohort 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Statin Only
n=8 Participants
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
Placebo: A substance that has no therapeutic effect and will act as a control.
|
Statin and Epicatechin
n=11 Participants
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
Pure epicatechin capsules (50mg): Epicatechin is a compound found naturally in dark chocolate.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.38 years
STANDARD_DEVIATION 11.46 • n=8 Participants
|
53 years
STANDARD_DEVIATION 7.69 • n=11 Participants
|
55.69 years
STANDARD_DEVIATION 3.804 • n=19 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=8 Participants
|
2 Participants
n=11 Participants
|
3 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=8 Participants
|
9 Participants
n=11 Participants
|
16 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body weight (kg)
|
87.48 kg
STANDARD_DEVIATION 2.79 • n=8 Participants
|
85.65 kg
STANDARD_DEVIATION 3.23 • n=11 Participants
|
86.42 kg
STANDARD_DEVIATION 3.04 • n=19 Participants
|
|
BMI (kg/m^2)
|
29.32 kg/m2
STANDARD_DEVIATION 1.45 • n=8 Participants
|
28.91 kg/m2
STANDARD_DEVIATION 0.68 • n=11 Participants
|
29.12 kg/m2
STANDARD_DEVIATION 0.2899 • n=19 Participants
|
|
Cholesterol (mg/dL)
|
224.4 mg/dL
STANDARD_DEVIATION 16.71 • n=8 Participants
|
247.7 mg/dL
STANDARD_DEVIATION 12.18 • n=11 Participants
|
236.1 mg/dL
STANDARD_DEVIATION 16.48 • n=19 Participants
|
|
HDL (mg/dL)
|
45.75 mg/dL
STANDARD_DEVIATION 3.74 • n=8 Participants
|
45.91 mg/dL
STANDARD_DEVIATION 3.1 • n=11 Participants
|
45.83 mg/dL
STANDARD_DEVIATION 0.1131 • n=19 Participants
|
|
LDL (mg/dL)
|
140.9 mg/dL
STANDARD_DEVIATION 15.73 • n=8 Participants
|
162 mg/dL
STANDARD_DEVIATION 8.9 • n=11 Participants
|
151.5 mg/dL
STANDARD_DEVIATION 14.92 • n=19 Participants
|
|
Cholesterol non-HDL (mg/dL)
|
178.6 mg/dL
STANDARD_DEVIATION 16.62 • n=8 Participants
|
193.9 mg/dL
STANDARD_DEVIATION 13.7 • n=11 Participants
|
186.3 mg/dL
STANDARD_DEVIATION 10.82 • n=19 Participants
|
|
Triglycerides
|
214.1 mg/dL
STANDARD_DEVIATION 35.57 • n=8 Participants
|
254.6 mg/dL
STANDARD_DEVIATION 24.72 • n=11 Participants
|
234.4 mg/dL
STANDARD_DEVIATION 28.64 • n=19 Participants
|
|
LDL particle number
|
1887 nmol/L
STANDARD_DEVIATION 197.9 • n=8 Participants
|
2022 nmol/L
STANDARD_DEVIATION 76.53 • n=11 Participants
|
1955 nmol/L
STANDARD_DEVIATION 95.46 • n=19 Participants
|
|
Small LDL particle number
|
919 nmol/L
STANDARD_DEVIATION 120.6 • n=8 Participants
|
1007 nmol/L
STANDARD_DEVIATION 60.14 • n=11 Participants
|
963 nmol/L
STANDARD_DEVIATION 62.23 • n=19 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsCardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity.
Outcome measures
| Measure |
Statin Only
n=8 Participants
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
Placebo: A substance that has no therapeutic effect and will act as a control.
|
Statin and Epicatechin
n=11 Participants
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
Pure epicatechin capsules (50mg): Epicatechin is a compound found naturally in dark chocolate.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
|
|---|---|---|
|
Changes in Functional Capacity (VO2max)
|
0.3 ml/kg/min
Standard Deviation 2.86
|
0.01 ml/kg/min
Standard Deviation 4.57
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsBiomarker levels in the blood will be evaluated for correlation with changes in the skeletal muscle mitochondrial structure and function.
Outcome measures
| Measure |
Statin Only
n=8 Participants
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
Placebo: A substance that has no therapeutic effect and will act as a control.
|
Statin and Epicatechin
n=11 Participants
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
Pure epicatechin capsules (50mg): Epicatechin is a compound found naturally in dark chocolate.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
|
|---|---|---|
|
Changes in Blood-Based Biomarkers
HDL
|
-1.125 mg/dL
Standard Deviation 2.88
|
2.73 mg/dL
Standard Deviation 1.55
|
|
Changes in Blood-Based Biomarkers
LDL
|
-52.25 mg/dL
Standard Deviation 9.54
|
-59.73 mg/dL
Standard Deviation 10.2
|
|
Changes in Blood-Based Biomarkers
Cholesterol non-HDL
|
-49.62 mg/dL
Standard Deviation 16.99
|
-61.09 mg/dL
Standard Deviation 12.97
|
|
Changes in Blood-Based Biomarkers
Cholesterol
|
-50.75 mg/dL
Standard Deviation 16.51
|
-62 mg/dL
Standard Deviation 11.92
|
|
Changes in Blood-Based Biomarkers
Triglycerides
|
0.25 mg/dL
Standard Deviation 175.9
|
-58.55 mg/dL
Standard Deviation 76
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsBiomarker levels in the blood will be evaluated for correlation with changes in the skeletal muscle mitochondrial structure and function in nmol/L.
Outcome measures
| Measure |
Statin Only
n=8 Participants
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
Placebo: A substance that has no therapeutic effect and will act as a control.
|
Statin and Epicatechin
n=11 Participants
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
Pure epicatechin capsules (50mg): Epicatechin is a compound found naturally in dark chocolate.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
|
|---|---|---|
|
Changes in Blood-Based Biomarkers-Low Density Lipoprotein Particles
LDL particle number
|
-455.6 nmol/L
Standard Deviation 88.4
|
-736.14 nmol/L
Standard Deviation 158.6
|
|
Changes in Blood-Based Biomarkers-Low Density Lipoprotein Particles
small LDL particle number
|
-233 nmol/L
Standard Deviation 105.4
|
-391 nmol/L
Standard Deviation 96.26
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsTG/HDL is a calculated index used as a surrogate marker for insulin resistance, derived by dividing fasting triglyceride level by HDL cholesterol level (both typically measured in mg/dL). Lower ratios indicate healthier insulin sensitivity, while higher ratios indicate greater insulin resistance and cardiometabolic risk.
Outcome measures
| Measure |
Statin Only
n=8 Participants
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
Placebo: A substance that has no therapeutic effect and will act as a control.
|
Statin and Epicatechin
n=11 Participants
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
Pure epicatechin capsules (50mg): Epicatechin is a compound found naturally in dark chocolate.
Simvastatin (40mg): A cholesterol-lowering medication that blocks the production of cholesterol.
|
|---|---|---|
|
Changes in Triglycerides/HDL
|
0.71 Index
Standard Deviation 1.575
|
-1.39 Index
Standard Deviation 0.47
|
Adverse Events
Statin Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Statin and Epicatechin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pam Taub
University of California - San Diego Health
Phone: 858-246-2342
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place