The Effect of Chocolate on Vascular Function of Endurance Runners

Vascular Function Clinical Trial

Official title:

The Effect of Chocolate on Vascular Function of Endurance Runners

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440512
• Other study ID #: EC-161/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: November 20, 2024

Study information

• Verified date: May 2024
• Source: Aristotle University Of Thessaloniki
• Contact: Zacharias Vordos, PhD
• Phone: +306977136712
• Email: zvordos[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 20, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vascular Function

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Laboratory of Sports Medicine	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).