Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome

Healthy Athletes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444388
• Other study ID #: UEM005
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2020
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Athletes

Intervention

Dietary Supplement:
• cocoa
Sachets of 5 grams of cocoa daily supplementation
• Placebo
Sachets of 5 grams of maltodextrin daily supplementation

Locations

Country	Name	City	State
Spain	Universidad Europea de Madrid	Villaviciosa de Odón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal microbiota	Abundance of bacterial taxa determined by 16SRNAr gene sequencing	Changes from baseline to 10 weeks of intervention
Primary	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
Primary	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