Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome
1 other identifier
interventional
40
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 4, 2020
November 1, 2020
3 months
June 18, 2020
November 3, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Cocoa group
EXPERIMENTAL5 g/day of flavonoid-rich defatted cocoa for 10 weeks
Placebo group
PLACEBO COMPARATOR5 g/day of maltodextrin for 10 weeks
Interventions
Eligibility Criteria
You may qualify if:
- years of age
- high physical condition (VO2 ≥ 55 ml/kg/min)
- BMI 18-25 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Europea de Madrid
Villaviciosa de Odón, Madrid, 28670, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mar Larrosa, PhD
Universidad Europea de Madrid
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tenure Professor
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 23, 2020
Study Start
July 1, 2020
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
November 4, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share