PROMETHEO: Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis

• Sponsor: Universidad Europea de Madrid (Other)
• Overall Status: Completed
• CT.gov ID: NCT04301583
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 12.6

Study Details

Study Description

Brief Summary

The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial exercise adaptations.

Condition or Disease	Intervention/Treatment	Phase
Athletes	Dietary Supplement: procyanidin B2 enriched cocoa	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Sachets
• Primary Purpose: Basic Science
• Official Title: Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Procyanidin B2 enriched cocoa Participants receiving cocoa capsules	Dietary Supplement: procyanidin B2 enriched cocoa; Volunteers will intake 5 grams per day of dietary supplement for 10 weeks
Placebo Comparator: Placebo group Participants maltodextrin capsules	Dietary Supplement: procyanidin B2 enriched cocoa; Volunteers will intake 5 grams per day of dietary supplement for 10 weeks

Outcome Measures

Primary Outcome Measures

1. Difference in mitochondrial number [10 weeks]

   Number of mitochondria in blood cells measured by qPCR using mitochondrial COX1 gene and beta globin as housekeeping nuclear gene

2. Difference in exercise performance [10 weeks]

   Maximum oxygen consumption of incomplete pulmonary gas exchange on VO2 max - Powers - Citado por 318 determination of cardiorespiratory fitness and training … - Clark - Citado por 180 Maximum oxygen consumption

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Men/Women

• Age between 18 and 45 years

• Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min

Exclusion Criteria:

• Smoke

• Any chronic disease

• Intake of nutritional or ergogenic supplements

• Chronic medication

• Cocoa allergy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Europea de Madrid	Villaviciosa de Odón	Madrid	Spain	28670

Sponsors and Collaborators

• Universidad Europea de Madrid

Investigators

• Principal Investigator: Mar Larrosa, Universidad Europea de Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mar Larrosa, Tenure Professor, Universidad Europea de Madrid
• ClinicalTrials.gov Identifier: NCT04301583
• Other Study ID Numbers: UEM004
• First Posted: Mar 10, 2020
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Proanthocyanidin; Procyanidin

Study Results

No Results Posted as of Nov 4, 2020