The Effect of Chocolate on Vascular Function of Endurance Runners

NCT06440512 | Not Yet Recruiting

• 1 other identifier: EC-161/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Function

Keywords

arterial stiffness; aerobic fitness; chocolate; polyphenols; endurance runners

Outcome Measures

Primary Outcomes (6)

• CF-PWV (Carotid-Femoral Pulse Wave Velocity)

  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)

  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

  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)

  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

  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

  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).

Study Arms (2)

A Chocolate Arm

EXPERIMENTAL

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; Other: White chocolate Intervention

B Chocolate Arm

EXPERIMENTAL

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; Other: White chocolate Intervention

Interventions

Dark chocolate Intervention OTHER

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.

A Chocolate Arm; B Chocolate Arm

White chocolate Intervention OTHER

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.

A Chocolate Arm; B Chocolate Arm

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Laboratory of Sports Medicine

Thessaloniki, 57001, Greece

Location

Study Officials

• Evangelia Kouidi, Professor

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zacharias Vordos, PhD

CONTACT

+306977136712; zvordos@hotmail.com

Asterios Deligiannis, Professor

CONTACT

+302310992181; adeligia@phed.auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Τhe study does not use the method of blind evaluation due to the nature of the interventions, which are easily identifiable by the participants
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of the Laboratory of Sports Medicine

Model Details: This study employs a crossover design to investigate the effects of chocolate consumption on vascular function of endurance runners. Participants will undergo multiple treatment periods where they will receive either dark chocolate or white chocolate, followed by washout periods to minimize carryover effects. The order of treatment administration will be randomized to mitigate potential sequence effects. Outcome measures will be assessed at the end of each treatment period to evaluate the impact of chocolate consumption on vascular function, athletic performance and other relevant outcomes.

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 4, 2024
• Study Start: June 10, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 20, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

GR (1)