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临床试验/NCT06908941
NCT06908941已完成不适用

The Cardiovascular Benefits of Dark Chocolate Supplementation Before High-intensity Resistance Exercise in the Early Follicular and Mid-luteal Phases of the Menstrual Cycle

National Cheng Kung University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Finger-Toe Pulse Wave Velocity (ftPWV)

研究概览

简要总结

This study investigates the effects of 85% dark chocolate supplementation on vascular function and nitric oxide (NO) levels during high-intensity resistance exercise in healthy women across menstrual phases. Using a randomized crossover design, 31 women consumed either dark chocolate or milk chocolate before exercising during the early follicular and mid-luteal phases. Vascular markers, including pulse wave velocity (ftPWV), arterial stiffness, blood pressure, and plasma NO levels, were measured at multiple time points.

详细描述

Background:

Dark chocolate, rich in flavanols, may support vascular health by reducing arterial stiffness and blood pressure across menstrual phases. This study examined the effects of 85% dark chocolate on nitric oxide (NO) levels and vascular function during high-intensity resistance exercise in healthy women across the early follicular and mid-luteal phases.

Methods:

Thirty-one healthy women (aged 20-30 years) with regular menstrual cycles completed a randomized, crossover study (conducted at National Chung Cheng University, Sep-Dec 2023). Participants consumed either 85% dark chocolate or milk chocolate (1g/kg body weight) before high-intensity resistance exercise during the early follicular (days 2-5) and mid-luteal (days 18-24) phases of two menstrual cycles. Finger-toe pulse wave velocity (ftPWV), arterial stiffness, blood pressure, and plasma NO levels were measured at rest, 2 hours after chocolate consumption (baseline), immediately post-exercise (T0), and at 60 (T60) and 120 (T120) minutes post-exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Double-blind

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •the healthy adult women,
  • •aged 20-30 years, from a local university campus,
  • •had a regular menstrual cycles in the past three months.

排除标准

  • •(1) irregular menstrual cycles (menstrual cycle length < 21 or > 35 days in the past three months),
  • •(2) pregnancy or lactation in the past year,
  • •(3) history of cardiovascular or uterine surgery in the past six months,
  • •(4) use of contraceptives or other female hormone medications,
  • •(5) smoking or alcohol consumption habits,
  • •(6) hypertension (blood pressure > 140/90 mmHg), chronic diseases, heart disease, or other cardiovascular conditions, (7) allergy to cocoa products, nuts, or fruits.

研究组 & 干预措施

Early Follicular

Experimental

Participants consumed either 85% dark chocolate or milk chocolate (1g/kg body weight) before high-intensity resistance exercise during the early follicular (days 2-5) phases of two menstrual cycles.

干预措施: milk chocolate (Dietary Supplement)

Early Follicular

Experimental

Participants consumed either 85% dark chocolate or milk chocolate (1g/kg body weight) before high-intensity resistance exercise during the early follicular (days 2-5) phases of two menstrual cycles.

干预措施: high-intensity resistance exercise (Behavioral)

Mid-Luteal

Active Comparator

Participants consumed either 85% dark chocolate or milk chocolate (1g/kg body weight) before high-intensity resistance exercise during the mid-luteal (days 18-24) phases of two menstrual cycles.

干预措施: milk chocolate (Dietary Supplement)

Mid-Luteal

Active Comparator

Participants consumed either 85% dark chocolate or milk chocolate (1g/kg body weight) before high-intensity resistance exercise during the mid-luteal (days 18-24) phases of two menstrual cycles.

干预措施: high-intensity resistance exercise (Behavioral)

Mid-Luteal

Active Comparator

Participants consumed either 85% dark chocolate or milk chocolate (1g/kg body weight) before high-intensity resistance exercise during the mid-luteal (days 18-24) phases of two menstrual cycles.

干预措施: dark chocolate (Dietary Supplement)

Early Follicular

Experimental

Participants consumed either 85% dark chocolate or milk chocolate (1g/kg body weight) before high-intensity resistance exercise during the early follicular (days 2-5) phases of two menstrual cycles.

干预措施: dark chocolate (Dietary Supplement)

结局指标

主要结局

Finger-Toe Pulse Wave Velocity (ftPWV)

时间窗: Finger-toe pulse wave velocity (ftPWV) were measured at rest, 2 hours after chocolate consumption (baseline), immediately post-exercise (T0), and at 60 (T60) and 120 (T120) minutes post-exercise.

Measurements at other time points are taken while participants are resting in the laboratory. Firstly, sensors for photoplethysmography (PPG) were placed on the right index finger and right big toe of the participants. These sensors were marked with an oily pen to ensure consistent placement throughout the experiment. The signals were then amplified using a Biopec MP150 (MP150, Biopac Systems Inc., Goleta, CA, USA), with each physiological signal collected for at least 150 seconds. The signals were analyzed using MATLAB to calculate the time difference between the two pulse waves. The length of the participant's body segments ( sternum to the right index finger, and sternum to the big toe of the right foot) was measured, and this value was divided by the average difference between 10 pulse waves (in the stable interval of 150 seconds) to calculate the ftPWV value (m/s).

次要结局

  • Arterial Index(Arterial index (API and AVI) were measured at rest, 2 hours after chocolate consumption (baseline), immediately post-exercise (T0), and at 60 (T60) and 120 (T120) minutes post-exercise.)

研究者

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

Cheng-Shiun He, PhD

Professor

National Cheng Kung University

研究点 (1)

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