NCT01671514

Brief 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. 1.Patients with heart failure (HF) and type 2 diabetes (DM2) and
  2. 2.Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed by VO2 max)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

2.4 years

First QC Date

August 20, 2012

Last Update Submit

June 1, 2015

Conditions

Heart FailureType 2 Diabetes

Keywords

mitochondrial biogenesisskeletal muscleepicatechin

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in exercise capacity

    Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max.

    Baseline and 3 months

  • Change from baseline in skeletal muscle metabolism

    The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy

    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.

    Baseline and 3 months

Other Outcomes (1)

  • Change from baseline in quality of life, health, and nutrition questionnaires

    Baseline and 3 months

Study Arms (2)

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.

Dietary Supplement: Epicatechin-enriched dark chocolateOther: 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.

Dietary Supplement: Epicatechin-enriched dark chocolateOther: Low-epicatechin dark chocolate

Interventions

Epicatechin-enriched dark chocolateDIETARY_SUPPLEMENT

For experimental purposes, subjects will take one square of epicatechin-enriched dark chocolate per day for 90 days.

Heart failure/diabetesSedentary
Low-epicatechin dark chocolateOTHER

As a placebo control, subjects will take 1 square of low-epicatechin chocolate per day for 90 days.

Heart failure/diabetesSedentary

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, inactive individuals
  • BMI 27-32

You may not qualify if:

  • Smoking or quit smoking less than 1 year prior to enrollment
  • Currently taking Coumadin or Pradaxa.
  • Heart failure and diabetes patients:
  • Medically diagnosed with heart failure and diabetes
  • No significant HbA1C fluctuations in past 6 months
  • Currently taking Insulin
  • Currently taking Coumadin or Pradaxa.
  • Smoking or quit smoking less than 1 year prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • 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.

    PMID: 22376256BACKGROUND

MeSH Terms

Conditions

Heart FailureDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pam Taub, MD

    Assistant Professor of Medicine, University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 23, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

US(1)