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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06440512
Other study ID # EC-161/2023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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).
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