NCT03897114

Brief Summary

Athletes consume an extra of nutritional supplements every day with the purpose of improving their athletic performance, sometimes without being aware of their health. Cocoa could be a good nutritional supplement for athletes without causing them adverse effects. One of the most common health concerns in athletes are gastrointestinal problems. The cause of these problems seem to be a compendium of physiological and mechanical causes that are altered due to nutritional factors. Currently, there is no assay in which a nutritional intervention study has been proposed over time of training, in order to improve the gastrointestinal problems associated with the performance of physical exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 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

Study Start

First participant enrolled

September 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

March 4, 2019

Last Update Submit

April 26, 2021

Conditions

Healthy Subjects

Keywords

Nutritional SupplementCocoaPrebioticPhysical ExerciseGut Microbiota

Outcome Measures

Primary Outcomes (1)

  • Measurement of fat mass

    Energy X-ray absorptiometry (DEXA ).

    Fat mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention

Secondary Outcomes (9)

  • Measurement of lean mass

    Lean mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention

  • Sport performance test.

    Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention

  • Sport performance test 2.

    Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention

  • Change in eating habits.

    Lifestyle will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention.

  • Change in Gut Microbiota

    Gut microbiota will be analyzed at the beginning (basiline dose) and after 10 weeks of intervention.

  • +4 more secondary outcomes

Study Arms (2)

Cocoa group

EXPERIMENTAL

The cocoa will be provided in sachets. The intervention will be carried out for 10 weeks. Cocoa is provided in a single daily dose of 5 g, which contains 83 mg of flavonoids per gram of cocoa (dose at which a prebiotic effect has been shown).

Dietary Supplement: Cocoa group

Placebo group

PLACEBO COMPARATOR

Maltodextrin will be supplied as a placebo, which will be provided in sachets. Athletes will take 5g of product per day.

Dietary Supplement: Placebo group

Interventions

Cocoa groupDIETARY_SUPPLEMENT

Athletes perform the same training program and they take 5 g of cocoa (83 mg of flavonoids per gram of cocoa) mixed with low-fat milk for 10 weeks.

Cocoa group
Placebo groupDIETARY_SUPPLEMENT

The athletes perform the same training program and they take for 10 weeks 5 g maltodextrin mixed with low-fat milk for 10 weeks

Placebo group

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHigh performance sportsmen
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men.
  • Age between 18 and 50 years
  • Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min

You may not qualify if:

  • Intake of antibiotics (3 months before the trial) or any chronical medication.
  • Intake of probiotics, prebiotics or any type of food or ergogenic supplements.
  • To be vegetarian or vegan
  • Smoke.
  • Have documented gastrointestinal diseases (ulcers, irritable bowel, ulcerative colitis, Crohn's disease, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jose Ángel García Merino

Villaviciosa de Odón, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • María del Mar Larrosa Pérez, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Cocoa and maltodextrin (placebo) are provided in identical sachets which are identified just with the letters A and B.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double blind placebo controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tenure Professor

Study Record Dates

First Submitted

March 4, 2019

First Posted

April 1, 2019

Study Start

September 1, 2017

Primary Completion

February 20, 2019

Study Completion

December 31, 2020

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations

ES(1)