Heart FailureNCT01671514
Effects of Dark Chocolate on Exercise Capacity, and Mitochondrial Structure and Function
A study testing Epicatechin-enriched dark chocolate and Low-epicatechin dark chocolate in people with Heart Failure and Type 2 Diabetes, run by University of California, San Diego at 1 site in United States.
Trial summary
The major goal of this study is to characterize the ability of dark chocolate enriched in epicatechin (a component of dark chocolate) to improve the structural and functional features of mitochondria in two groups 1. Patients with heart failure (HF) and type 2 diabetes (DM2) and 2. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Type 2 Diabetes
- What is being tested?
- Epicatechin-enriched dark chocolate and Low-epicatechin dark chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, inactive individuals
- BMI 27-32
- Medically diagnosed with heart failure and diabetes
- No significant HbA1C fluctuations in past 6 months
Who cannot join
- Smoking or quit smoking less than 1 year prior to enrollment
- Currently taking Coumadin or Pradaxa.
- Heart failure and diabetes patients:
- Currently taking Insulin
- Currently taking Coumadin or Pradaxa.
- Smoking or quit smoking less than 1 year prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Effects of Epicatechin-enriched Dark Chocolate on Mitochondrial Function and Exercise Capacity in Patients With Both Diabetes and Heart Failure and in Sedentary Individuals
The major goal of this study is to characterize the ability of dark chocolate enriched in epicatechin (a component of dark chocolate) to improve the structural and functional features of mitochondria in two groups
- Patients with heart failure (HF) and type 2 diabetes (DM2) and
- Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed by VO2 max)
We propose that a 3 month treatment with dark chocolate will lead to a significant improvement in exercise capacity which will be secondary to the improvement in skeletal muscle structure from epicatechin.
Read the detailed description
The flavanol epicatechin (which is derived from cocoa and has no known toxicity in humans) has been shown in clinical trials to increase levels of nitric oxide (NO) as assessed by flow-mediated dilation (FMD) in the brachial artery and measurements of circulating NO in plasma. NO is thought to be an activator of PGC-1 alpha [PPAR (peroxisome proliferator-activated receptor) alpha coactivator 1] which stimulates mitochondrial biogenesis. In both patients with heart failure and diabetes there is nitric oxide deficiency and mitochondrial dysfunction. In our proposed double-blinded placebo controlled clinical trial, we will test the hypothesis that chronic administration of epicatechin to patients with both heart failure and diabetes will increase levels of NO and PGC-1 alpha leading to increased mitochondrial biogenesis and improved mitochondrial function. We believe similar changes will occur in sedentary individuals.
In a preliminary study with 5 patients with heart failure and diabetes (conducted under UCSD IRB protocol number #090688) we have shown that epicatechin enriched dark chocolate improves mitochondrial structure (Taub PR, Ramirez-Sanchez I, Ciaraldi TP, et al. Alterations in Skeletal Muscle Indicators of Mitochondrial Structure and Biogenesis in Patients with Type 2 Diabetes and Heart Failure: Effects of Epicatechin Rich Cocoa. Clin Transl Sci. 2011;5(1):43-47.)
- Conditions
- Heart Failure, Type 2 Diabetes
- Being tested
- Epicatechin-enriched dark chocolate, Low-epicatechin dark chocolate
- Keywords
- mitochondrial biogenesis, skeletal muscle, epicatechin
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicatechin-enriched dark chocolateDietary supplement
For experimental purposes, subjects will take one square of epicatechin-enriched dark chocolate per day for 90 days.
Low-epicatechin dark chocolateOther
As a placebo control, subjects will take 1 square of low-epicatechin chocolate per day for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary | Experimental | The sedentary arm will be randomly assigned to either epicatechin-enriched dark chocolate or low-epicatechin dark chocolate as a placebo. Participants will take one square of chocolate per day for 90 days. Receives: Dietary Supplement: Epicatechin-enriched dark chocolate; Other: Low-epicatechin dark chocolate |
| Heart failure/diabetes | Experimental | The heart failure/diabetes arm will be randomly assigned to either epicatechin-enriched dark chocolate or low-epicatechin dark chocolate as a placebo. Participants will take one square of chocolate per day for 90 days. Receives: Dietary Supplement: Epicatechin-enriched dark chocolate; Other: Low-epicatechin dark chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in exercise capacity
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max.
Measured: Baseline and 3 months
Change from baseline in skeletal muscle metabolism
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
Measured: Baseline and 3 months
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- The Hershey Company
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
- Investigators
- Pam Taub, MD, Principal investigator, Assistant Professor of Medicine, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671514
- Sponsor's protocol ID
- UCSD IRB 111680
- Status last verified
- Jun 2015
- First submitted
- 20 Aug 2012
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taub PR, Ramirez-Sanchez I, Ciaraldi TP, Perkins G, Murphy AN, Naviaux R, Hogan M, Maisel AS, Henry RR, Ceballos G, Villarreal F. Alterations in skeletal muscle indicators of mitochondrial structure and biogenesis in patients with type 2 diabetes and heart failure: effects of epicatechin rich cocoa. Clin Transl Sci. 2012 Feb;5(1):43-7. doi: 10.1111/j.1752-8062.2011.00357.x. Epub 2011 Nov 7.
PubMed 22376256
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Epicatechin-enriched Dark Chocolate on Mitochondrial Function and Exercise Capacity in Patients With Both Diabetes and Heart Failure and in Sedentary Individuals
- ClinicalTrials.gov ID
- NCT01671514
- Acronym / sponsor ID
- UCSD IRB 111680
- Conditions
- Heart Failure, Type 2 Diabetes
- Keywords
- mitochondrial biogenesis, skeletal muscle, epicatechin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- The Hershey Company
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major goal of this study is to characterize the ability of dark chocolate enriched in epicatechin (a component of dark chocolate) to improve the structural and functional features of mitochondria in two groups
- Patients with heart failure (HF) and type 2 diabetes (DM2) and
- Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed by VO2 max)
We propose that a 3 month treatment with dark chocolate will lead to a significant improvement in exercise capacity which will be secondary to the improvement in skeletal muscle structure from epicatechin.
Detailed description
The flavanol epicatechin (which is derived from cocoa and has no known toxicity in humans) has been shown in clinical trials to increase levels of nitric oxide (NO) as assessed by flow-mediated dilation (FMD) in the brachial artery and measurements of circulating NO in plasma. NO is thought to be an activator of PGC-1 alpha [PPAR (peroxisome proliferator-activated receptor) alpha coactivator 1] which stimulates mitochondrial biogenesis. In both patients with heart failure and diabetes there is nitric oxide deficiency and mitochondrial dysfunction. In our proposed double-blinded placebo controlled clinical trial, we will test the hypothesis that chronic administration of epicatechin to patients with both heart failure and diabetes will increase levels of NO and PGC-1 alpha leading to increased mitochondrial biogenesis and improved mitochondrial function. We believe similar changes will occur in sedentary individuals.
In a preliminary study with 5 patients with heart failure and diabetes (conducted under UCSD IRB protocol number #090688) we have shown that epicatechin enriched dark chocolate improves mitochondrial structure (Taub PR, Ramirez-Sanchez I, Ciaraldi TP, et al. Alterations in Skeletal Muscle Indicators of Mitochondrial Structure and Biogenesis in Patients with Type 2 Diabetes and Heart Failure: Effects of Epicatechin Rich Cocoa. Clin Transl Sci. 2011;5(1):43-47.)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary | Experimental | Dietary Supplement: Epicatechin-enriched dark chocolate, Other: Low-epicatechin dark chocolateThe sedentary arm will be randomly assigned to either epicatechin-enriched dark chocolate or low-epicatechin dark chocolate as a placebo. Participants will take one square of chocolate per day for 90 days. |
| Heart failure/diabetes | Experimental | Dietary Supplement: Epicatechin-enriched dark chocolate, Other: Low-epicatechin dark chocolateThe heart failure/diabetes arm will be randomly assigned to either epicatechin-enriched dark chocolate or low-epicatechin dark chocolate as a placebo. Participants will take one square of chocolate per day for 90 days. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy, inactive individuals
- BMI 27-32
- Medically diagnosed with heart failure and diabetes
- No significant HbA1C fluctuations in past 6 months
Key exclusion criteria (6 listed)
- Smoking or quit smoking less than 1 year prior to enrollment
- Currently taking Coumadin or Pradaxa.
- Currently taking Insulin
- Currently taking Coumadin or Pradaxa.
- Smoking or quit smoking less than 1 year prior to enrollment
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 |
|---|---|---|
| Epicatechin-enriched dark chocolateFor experimental purposes, subjects will take one square of epicatechin-enriched dark chocolate per day for 90 days. | Dietary supplement | Heart failure/diabetes, Sedentary |
| Low-epicatechin dark chocolateAs a placebo control, subjects will take 1 square of low-epicatechin chocolate per day for 90 days. | Other | Heart failure/diabetes, Sedentary |
Primary outcome
Change from baseline in exercise capacity
Time frame: Baseline and 3 months
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max.
Change from baseline in skeletal muscle metabolism
Time frame: Baseline and 3 months
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
Time frame: Baseline and 3 months
Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Background: PubMed 22376256Taub PR, Ramirez-Sanchez I, Ciaraldi TP, Perkins G, Murphy AN, Naviaux R, Hogan M, Maisel AS, Henry RR, Ceballos G, Villarreal F. Alterations in skeletal muscle indicators of mitochondrial structure and biogenesis in patients with type 2 diabetes and heart failure: effects of epicatechin rich cocoa. Clin Transl Sci. 2012 Feb;5(1):43-7. doi: 10.1111/j.1752-8062.2011.00357.x. Epub 2011 Nov 7.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Pam Taub, MD principal investigator
Assistant Professor of Medicine, University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epicatechin-enriched dark chocolate and Low-epicatechin dark chocolate in people with Heart Failure and Type 2 Diabetes, run by University of California, San Diego 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 4 inclusion and 6 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 3 Jun 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 exercise capacity (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. 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 NCT01671514, 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 3 Jun 2015.