NCT04301583

Brief Summary

The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial exercise adaptations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

March 5, 2020

Last Update Submit

November 3, 2020

Conditions

Athletes

Outcome Measures

Primary Outcomes (2)

  • Difference in mitochondrial number

    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

    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

Study Arms (2)

Procyanidin B2 enriched cocoa

ACTIVE COMPARATOR

Participants receiving cocoa capsules

Dietary Supplement: procyanidin B2 enriched cocoa

Placebo group

PLACEBO COMPARATOR

Participants maltodextrin capsules

Dietary Supplement: procyanidin B2 enriched cocoa

Interventions

procyanidin B2 enriched cocoaDIETARY_SUPPLEMENT

Volunteers will intake 5 grams per day of dietary supplement for 10 weeks

Placebo groupProcyanidin B2 enriched cocoa

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location

Study Officials

  • Mar Larrosa

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Sachets
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tenure Professor

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 10, 2020

Study Start

June 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available

Locations

ES(1)