The Effect of Chocolate on Vascular Function of Endurance Runners

May 31, 2024 updated by: Evangelia Kouidi, Aristotle University Of Thessaloniki
The aim of this study is to examine the effects of chocolate on the vascular function of endurance runners through a crossover study involving male runners consuming both dark and white chocolate.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be male endurance runners who will receive both black and white chocolate interventions. Arterial stiffness, cardiovascular parameters, respiratory parameters, and running performance will be assessed before and after each intervention period. The study will involve a two-week intervention period for each type of chocolate, with a washout period in between. The primary outcome measure will be arterial stiffness, while secondary outcome measures will include cardiovascular and respiratory parameters, as well as running performance. The study is expected to provide insights into the effects of chocolate consumption on vascular function in endurance athletes.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Thessaloniki, Greece, 57001
        • Laboratory of Sports Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gender: Male
  • Age: 25-55 years
  • Healthy status
  • Active endurance runner
  • Regular physical activity (at least 3 times per week)
  • Availability on specific days and times for research sessions
  • Willingness and consistency

Exclusion Criteria:

  • Allergies or Intolerances: Participants with known allergies or intolerances to chocolate or any of its ingredients.
  • Cardiovascular Diseases: Participants with known cardiovascular diseases or history of cardiac episodes.
  • Metabolic Disorders: Individuals with diabetes or other metabolic disorders that may affect glucose and insulin metabolism.
  • Contradictory Diet: Individuals following specific diets that may affect the study, such as high or low flavonoid diets.
  • Medication Use: Individuals taking medications that affect vascular function, such as antihypertensives or anticoagulants.
  • Smoking: Smokers or individuals who have quit smoking within the last six months.
  • Substance Abuse: Individuals with a history of alcohol or substance abuse.
  • Patients with Chronic Diseases: Individuals with serious chronic diseases that may affect the study outcomes.
  • Participation in Other Studies: Individuals participating in other clinical trials or research that may affect the study outcomes.
  • Physical Condition: Individuals who are not regular runners or who do not exercise regularly at a level similar to other participants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Chocolate Arm

Intervention period 1:The group will consume 50 grams of dark chocolate daily for two weeks.

Washout period: Two-weeks

Intervention period 2: The group will consume 40 grams of white chocolate daily for two weeks.
Other: Dark chocolate Intervention
The intervention involves daily consumption of 50 grams of dark chocolate for a period of two weeks. The dark chocolate is provided in tablet form, and participants are instructed to consume it daily.
Other: White chocolate Intervention
The intervention involves daily consumption of 40 grams of white chocolate for a period of two weeks. The dark chocolate is provided in tablet form, and participants are instructed to consume it daily.
Experimental: B Chocolate Arm

Intervention period 1:The group will consume 40 grams of white chocolate daily for two weeks.

Washout period: Two-weeks

Intervention period 2: The group will consume 50 grams of dark chocolate daily for two weeks
Other: Dark chocolate Intervention
The intervention involves daily consumption of 50 grams of dark chocolate for a period of two weeks. The dark chocolate is provided in tablet form, and participants are instructed to consume it daily.
Other: White chocolate Intervention
The intervention involves daily consumption of 40 grams of white chocolate for a period of two weeks. The dark chocolate is provided in tablet form, and participants are instructed to consume it daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CF-PWV (Carotid-Femoral Pulse Wave Velocity)
Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Measurement of the velocity of the pressure wave between the carotid and femoral arteries, expressed in meters per second (m/s)
Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
AIx (Augmentation Index)
Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Measurement of arterial stiffness, calculated as the difference between the first and second systolic peaks of the arterial waveform, expressed as a percentage (%)
Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Exercise Time in Cardiopulmonary Exercise Testing
Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Total duration of exercise during cardiopulmonary exercise testing, measured in minutes.
Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
VO2max (Maximal Oxygen Uptake)
Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Maximum amount of oxygen consumed per minute during incremental exercise, expressed in milliliters per kilogram per minute (mL/kg/min)
Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
5km Time
Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Total time taken to complete a 5-kilometer run, measured in minutes and seconds.
Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
5km Speed
Time Frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Average speed during a 5-kilometer run, expressed in kilometers per hour (km/h).
Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Evangelia Kouidi, Professor, Aristotle University of Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 20, 2024

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EC-161/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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