MedDataX Logo

Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome

NCT ID: NCT04444388

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

It has recently been suggested that cocoa may improve exercise performance and recovery. This study aim to evaluate the plasma and fecal metabolome after 10 weeks of cocoa supplementation during the training period in recreational athletes to detect possible metabolites involved in the observed benefits of cocoa in athletes

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Athletes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cocoa group

5 g/day of flavonoid-rich defatted cocoa for 10 weeks

Group Type EXPERIMENTAL

cocoa

Intervention Type DIETARY_SUPPLEMENT

Sachets of 5 grams of cocoa daily supplementation

Placebo group

5 g/day of maltodextrin for 10 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Sachets of 5 grams of maltodextrin daily supplementation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cocoa

Sachets of 5 grams of cocoa daily supplementation

Intervention Type DIETARY_SUPPLEMENT

Placebo

Sachets of 5 grams of maltodextrin daily supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-45 years of age
* high physical condition (VO2 ≥ 55 ml/kg/min)
* BMI 18-25 kg/m2

Exclusion Criteria

* antibiotics intake during 3 months prior to the study,
* smoking
* nutritional complements
* ergogenic complements
* prebiotics
* probiotics
* vegetarian or vegan diet
* chronic medication
* gastrointestinal surgery
* Any diagnosed disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Europea de Madrid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mar Larrosa

Tenure Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mar Larrosa, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UEM005

Identifier Type: -

Identifier Source: org_study_id