Clinical trial NCT06440512: The Effect of Chocolate on Vascular Function of Endurance Runners
Official title: The Effect of Chocolate on Vascular Function of Endurance Runners
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vascular Function
Keywords: arterial stiffness
aerobic fitness
chocolate
polyphenols
endurance runners
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 50
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CF-PWV (Carotid-Femoral Pulse Wave Velocity)
timeFrame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
measure: AIx (Augmentation Index)
timeFrame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
measure: Exercise Time in Cardiopulmonary Exercise Testing
timeFrame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
measure: VO2max (Maximal Oxygen Uptake)
timeFrame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
measure: 5km Time
timeFrame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
measure: 5km Speed
timeFrame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Laboratory of Sports Medicine
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Evangelia Kouidi, Professor
role: PRINCIPAL_INVESTIGATOR
References: