An interventional study of Pure epicatechin capsules (50mg) and Simvastatin (40mg) in Statin Intolerance, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
The purpose of this study is to gain insight into the side-effects of statin consumption, and assess the ability of epicatechin (a compound in dark chocolate) to counteract or reverse these changes. The investigators' prior research has shown that epicatechin can improve skeletal muscle structure and mitochondrial (which gives us energy) structure.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
The study will be a double blind placebo controlled study where subjects will be randomized to either of two groups:
232 studies on the registry are indexed under Muscular Diseases; 54 are open to participants now.
This study's enrollment of 19 is below the median of 38 across 134 interventional studies indexed under Muscular Diseases.
Browse Muscular Diseases studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subject will consume simvastatin (40mg) and placebo once daily for 3 months.
Drug: Simvastatin (40mg) · Other: Placebo
The subject will consume simvastatin (40mg) and pure epicatechin capsules (50mg) once daily for 3 months.
Dietary Supplement: Pure epicatechin capsules (50mg) · Drug: Simvastatin (40mg)
Epicatechin is a compound found naturally in dark chocolate.
A cholesterol-lowering medication that blocks the production of cholesterol.
A substance that has no therapeutic effect and will act as a control.
Changes in Functional Capacity (VO2max)
Cardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity.
Time frame: Baseline and 3 months
Changes in Blood-Based Biomarkers
Biomarker levels in the blood will be evaluated for correlation with changes in the skeletal muscle mitochondrial structure and function.
Time frame: Baseline and 3 months
Changes in Blood-Based Biomarkers-Low Density Lipoprotein Particles
Biomarker levels in the blood will be evaluated for correlation with changes in the skeletal muscle mitochondrial structure and function in nmol/L.
Time frame: Baseline and 3 months
Changes in Triglycerides/HDL
TG/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.
Time frame: Baseline and 3 months
| Milestone | Statin Only | Statin and Epicatechin |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 0 | 0 |
| Milestone | Statin Only | Statin and Epicatechin |
|---|---|---|
| Started | 5 | 8 |
| Completed | 5 | 8 |
| Not completed | 0 | 0 |
Cardiopulmonary exercise protocol will be used to measure VO2max to assess functional capacity.
| ml/kg/min | Statin Only | Statin and Epicatechin |
|---|---|---|
| Changes in Functional Capacity (VO2max) | 0.3 ± 2.86 | 0.01 ± 4.57 |
Biomarker levels in the blood will be evaluated for correlation with changes in the skeletal muscle mitochondrial structure and function.
| mg/dL | Statin Only | Statin and Epicatechin |
|---|---|---|
| Cholesterol | -50.75 ± 16.51 | -62 ± 11.92 |
| HDL | -1.125 ± 2.88 | 2.73 ± 1.55 |
| LDL | -52.25 ± 9.54 | -59.73 ± 10.2 |
| Cholesterol non-HDL | -49.62 ± 16.99 | -61.09 ± 12.97 |
| Triglycerides | 0.25 ± 175.9 | -58.55 ± 76 |
Biomarker levels in the blood will be evaluated for correlation with changes in the skeletal muscle mitochondrial structure and function in nmol/L.
| nmol/L | Statin Only | Statin and Epicatechin |
|---|---|---|
| LDL particle number | -455.6 ± 88.4 | -736.14 ± 158.6 |
| small LDL particle number | -233 ± 105.4 | -391 ± 96.26 |
TG/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.
| Index | Statin Only | Statin and Epicatechin |
|---|---|---|
| Changes in Triglycerides/HDL | 0.71 ± 1.575 | -1.39 ± 0.47 |
Collected over Baseline and 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Statin Only | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Statin and Epicatechin | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | Statin Only | Statin and Epicatechin | Total |
|---|---|---|---|
| Mean | 58.38 ± 11.46 | 53 ± 7.69 | 55.69 ± 3.804 |
| Sex: Female, Male(Participants) | Statin Only | Statin and Epicatechin | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 7 | 9 | 16 |
| Race and Ethnicity Not Collected(Participants) | Statin Only | Statin and Epicatechin | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Body weight (kg)(kg) | Statin Only | Statin and Epicatechin | Total |
|---|---|---|---|
| Mean | 87.48 ± 2.79 | 85.65 ± 3.23 | 86.42 ± 3.04 |
| BMI (kg/m^2)(kg/m2) | Statin Only | Statin and Epicatechin | Total |
|---|---|---|---|
| Mean | 29.32 ± 1.45 | 28.91 ± 0.68 | 29.12 ± 0.2899 |
| Cholesterol (mg/dL)(mg/dL) | Statin Only | Statin and Epicatechin | Total |
|---|---|---|---|
| Mean | 224.4 ± 16.71 | 247.7 ± 12.18 | 236.1 ± 16.48 |
| HDL (mg/dL)(mg/dL) | Statin Only | Statin and Epicatechin | Total |
|---|---|---|---|
| Mean | 45.75 ± 3.74 | 45.91 ± 3.1 | 45.83 ± 0.1131 |
| LDL (mg/dL)(mg/dL) | Statin Only | Statin and Epicatechin | Total |
|---|---|---|---|
| Mean | 140.9 ± 15.73 | 162 ± 8.9 | 151.5 ± 14.92 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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