Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome

Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome: Effects on Acute and Adaptive Exercise

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

Study Overview

• Status: Completed
• Conditions: Healthy Athletes
• Intervention / Treatment: Dietary supplement: cocoa; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cocoa group; 5 g/day of flavonoid-rich defatted cocoa for 10 weeks	Dietary supplement: cocoa; Sachets of 5 grams of cocoa daily supplementation
Placebo Comparator: Placebo group; 5 g/day of maltodextrin for 10 weeks	Dietary supplement: Placebo; Sachets of 5 grams of maltodextrin daily supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal microbiota	Abundance of bacterial taxa determined by 16SRNAr gene sequencing	Changes from baseline to 10 weeks of intervention
Fecal metabolome profile	Abundance of fecal metabolites, metabolic networks, and metabolic pathways determined by High Pressure Liquid Chromatography-Mass Spectrometry	Changes from baseline to 10 weeks of intervention
Plasma metabolome profile	Abundance of blood metabolites, metabolic networks, and metabolic pathways activity determined by High Pressure Liquid Chromatography-Mass Spectrometry	Changes from baseline to 10 weeks of intervention

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Investigators: Principal Investigator: Mar Larrosa, PhD, Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 20, 2020
• First Posted (Actual): June 23, 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

• Other Study ID Numbers: UEM005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No