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OpenTrials
Completed

NCT Number: NCT04444388

Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome

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

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Key information

Conditions

Healthy Athletes

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cocoa

Dietary Supplement

Sachets of 5 grams of cocoa daily supplementation

Placebo

Dietary Supplement

Sachets of 5 grams of maltodextrin daily supplementation

Primary outcomes

  1. Fecal microbiota

    Time frame: Changes from baseline to 10 weeks of intervention

    Abundance of bacterial taxa determined by 16SRNAr gene sequencing

  2. Fecal metabolome profile

    Time frame: Changes from baseline to 10 weeks of intervention

    Abundance of fecal metabolites, metabolic networks, and metabolic pathways determined by High Pressure Liquid Chromatography-Mass Spectrometry

  3. Plasma metabolome profile

    Time frame: Changes from baseline to 10 weeks of intervention

    Abundance of blood metabolites, metabolic networks, and metabolic pathways activity determined by High Pressure Liquid Chromatography-Mass Spectrometry

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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