Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis (PROMETHEO)

November 3, 2020 updated by: Mar Larrosa, Universidad Europea de Madrid
The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial exercise adaptations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Villaviciosa de Odón, Madrid, Spain, 28670
        • Universidad Europea de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men/Women
  • Age between 18 and 45 years
  • Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min

Exclusion Criteria:

  • Smoke
  • Any chronic disease
  • Intake of nutritional or ergogenic supplements
  • Chronic medication
  • Cocoa allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Procyanidin B2 enriched cocoa
Participants receiving cocoa capsules
Dietary supplement: procyanidin B2 enriched cocoa
Volunteers will intake 5 grams per day of dietary supplement for 10 weeks
Placebo Comparator: Placebo group
Participants maltodextrin capsules
Dietary supplement: procyanidin B2 enriched cocoa
Volunteers will intake 5 grams per day of dietary supplement for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mitochondrial number
Time Frame: 10 weeks
Number of mitochondria in blood cells measured by qPCR using mitochondrial COX1 gene and beta globin as housekeeping nuclear gene
10 weeks
Difference in exercise performance
Time Frame: 10 weeks

Maximum oxygen consumption

  • of incomplete pulmonary gas exchange on VO2 max - Powers - Citado por 318
  • determination of cardiorespiratory fitness and training … - Clark - Citado por 180 Maximum oxygen consumption
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Investigators

  • Principal Investigator: Mar Larrosa, Universidad Europea de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEM004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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