- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06908941
The Cardiovascular Benefits of Resistance Training and Dark Chocolate in Female Adults
The Cardiovascular Benefits of Dark Chocolate Supplementation Before High-intensity Resistance Exercise in the Early Follicular and Mid-luteal Phases of the Menstrual Cycle
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Chiayi County, Taiwan, Taiwan
- National Chung Cheng University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- the healthy adult women,
- aged 20-30 years, from a local university campus,
- had a regular menstrual cycles in the past three months.
Exclusion Criteria:
- (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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early Follicular
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.
|
Participants consumed 85% dark 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.
Participants consumed 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.
Participants performed high-intensity resistance exercise during the early follicular (days 2-5) and mid-luteal (days 18-24) phases of two menstrual cycles.
|
|
Active Comparator: Mid-Luteal
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.
|
Participants consumed 85% dark 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.
Participants consumed 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.
Participants performed high-intensity resistance exercise during the early follicular (days 2-5) and mid-luteal (days 18-24) phases of two menstrual cycles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Finger-Toe Pulse Wave Velocity (ftPWV)
Time Frame: 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.
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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).
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial Index
Time Frame: 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.
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The arterial pressure volume index (API) and arterial velocity pulse index (AVI) are measured using the PASESA AVE-2000 (PASESA, Tokyo, Japan) with a wrapped around the right upper arm of seated participants.
The API reflected the stiffness of peripheral arteries by assessing the pressure-volume relationship of the artery, while the AVI primarily reflected the stiffness of central arteries by analyzing the ratio of forward and reflected pressure waves.
Each measurement was taken three times, and the average of the three readings was recorded.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cheng-Shiun He Professor, National Chung Cheng University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CCUREC111122101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Informed Consent Form
Information identifier: CCUREC111122101Information comments: National Chung Cheng University Human Research Ethics Center
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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