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临床试验/NCT06440512
NCT06440512尚未招募不适用

The Effect of Chocolate on Vascular Function of Endurance Runners

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
5km Time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

盲法说明

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

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Dark chocolate Intervention (Other)

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.

干预措施: White chocolate Intervention (Other)

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

干预措施: Dark chocolate Intervention (Other)

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

干预措施: White chocolate Intervention (Other)

结局指标

主要结局

5km Time

时间窗: 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.

AIx (Augmentation Index)

时间窗: 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

时间窗: 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.

5km Speed

时间窗: 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).

CF-PWV (Carotid-Femoral Pulse Wave Velocity)

时间窗: 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)

VO2max (Maximal Oxygen Uptake)

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Evangelia Kouidi

Professor, Director of the Laboratory of Sports Medicine

Aristotle University Of Thessaloniki

研究点 (1)

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