Vascular Function Clinical Trial
Official title:
The Effect of Chocolate on Vascular Function of Endurance Runners
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.
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. |
Country | Name | City | State |
---|---|---|---|
Greece | Laboratory of Sports Medicine | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
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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