The Effect of Chocolate on Vascular Function of Endurance Runners

NCT ID: NCT06440512

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2024-11-20

Brief Summary

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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

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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

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Vascular Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Τhe study does not use the method of blind evaluation due to the nature of the interventions, which are easily identifiable by the participants

Study Groups

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A Chocolate Arm

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.

Group Type EXPERIMENTAL

Dark chocolate Intervention

Intervention Type OTHER

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

Intervention Type OTHER

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.

B Chocolate Arm

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

Group Type EXPERIMENTAL

Dark chocolate Intervention

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Evangelia Kouidi

Professor, Director of the Laboratory of Sports Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evangelia Kouidi, Professor

Role: PRINCIPAL_INVESTIGATOR

Aristotle University Of Thessaloniki

Locations

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Laboratory of Sports Medicine

Thessaloniki, , Greece

Site Status

Countries

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Greece

Central Contacts

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Zacharias Vordos, PhD

Role: CONTACT

+306977136712

Asterios Deligiannis, Professor

Role: CONTACT

+302310992181

Facility Contacts

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Evangelia Kouidi, Professor

Role: primary

Other Identifiers

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EC-161/2023

Identifier Type: -

Identifier Source: org_study_id

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