Vascular FunctionNCT06440512
The Effect of Chocolate on Vascular Function of Endurance Runners
A study testing Dark chocolate Intervention and White chocolate Intervention in people with Vascular Function, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Function
- What is being tested?
- Dark chocolate Intervention and White chocolate Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jun 2024to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Sports Medicine
Thessaloniki, 57001
Evangelia Kouidi, Professor, kouidi@phed.auth.gr
About this study
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.
Read the 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.
- Conditions
- Vascular Function
- Being tested
- Dark chocolate Intervention, White chocolate Intervention
- Keywords
- arterial stiffness, aerobic fitness, chocolate, polyphenols, endurance runners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark chocolate InterventionOther
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 InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Dark chocolate Intervention; Other: White chocolate Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (%)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Jun 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular FunctionStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Kouidi, Aristotle University Of Thessaloniki
- Investigators
- Evangelia Kouidi, Professor, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440512
- Sponsor's protocol ID
- EC-161/2023
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chocolate on Vascular Function of Endurance Runners
- ClinicalTrials.gov ID
- NCT06440512
- Acronym / sponsor ID
- EC-161/2023
- Conditions
- Vascular Function
- Keywords
- arterial stiffness, aerobic fitness, chocolate, polyphenols, endurance runners
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| A Chocolate Arm | Experimental | Other: Dark chocolate Intervention, Other: White chocolate InterventionIntervention 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. |
| B Chocolate Arm | Experimental | Other: Dark chocolate Intervention, Other: White chocolate InterventionIntervention 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 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Gender: Male
- Age: 25-55 years
- Healthy status
- Active endurance runner
- Regular physical activity (at least 3 times per week)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dark chocolate InterventionThe 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. | Other | A Chocolate Arm, B Chocolate Arm |
| White chocolate InterventionThe 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. | Other | A Chocolate Arm, B Chocolate Arm |
Primary outcome
CF-PWV (Carotid-Femoral Pulse Wave Velocity)
Time frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Measurement of the velocity of the pressure wave between the carotid and femoral arteries, expressed in meters per second (m/s)
AIx (Augmentation Index)
Time frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Measurement of arterial stiffness, calculated as the difference between the first and second systolic peaks of the arterial waveform, expressed as a percentage (%)
Exercise Time in Cardiopulmonary Exercise Testing
Time frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Total duration of exercise during cardiopulmonary exercise testing, measured in minutes.
VO2max (Maximal Oxygen Uptake)
Time frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Maximum amount of oxygen consumed per minute during incremental exercise, expressed in milliliters per kilogram per minute (mL/kg/min)
5km Time
Time frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Total time taken to complete a 5-kilometer run, measured in minutes and seconds.
5km Speed
Time frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).
Average speed during a 5-kilometer run, expressed in kilometers per hour (km/h).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelia Kouidi, Professor principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dark chocolate Intervention and White chocolate Intervention in people with Vascular Function, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zacharias Vordos, PhD (+306977136712, zvordos@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CF-PWV (Carotid-Femoral Pulse Wave Velocity) (time frame: Baseline and at the end of each 2-week intervention period (after consumption of dark chocolate and after consumption of white chocolate).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.