UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063209 |
|---|---|
| Receipt number | R000072346 |
| Scientific Title | Effects of cocoa supplementation and aerobic exercise on arterial stiffness in sedentary middle-to-late aged adults |
| Date of disclosure of the study information | 2026/10/07 |
| Last modified on | 2026/10/07 20:03:18 |
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Basic information
Public title
Effects of cocoa supplementation and aerobic exercise on arterial stiffness in sedentary middle-to-late aged adults
Acronym
COCO and Exercise Trial
Scientific Title
Effects of cocoa supplementation and aerobic exercise on arterial stiffness in sedentary middle-to-late aged adults
Scientific Title:Acronym
COCO and Exercise Trial
Region
| Asia(except Japan) |
Condition
Condition
Arterial stiffness
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 8 weeks of cocoa supplementation and aerobic exercise on arterial stiffness in sedentary middle-to-late adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Brachial-ankle pulse wave velocity (baPWV), measured at baseline and after 4 and 8 weeks of intervention.
Key secondary outcomes
Systolic blood pressure, diastolic blood pressure, and resting heart rate.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants in the COEX group consumed 100% cocoa powder daily at a dose of 0.17 g/kg/day for 8 weeks and participated in a supervised square dancing program three times per week for 8 weeks. Each session lasted 60 minutes and consisted of a 10-minute warm-up, 40 minutes of square dancing, and a 10-minute stretching period.
Exercise intensity was maintained at 50% to 70% of age-predicted maximum heart rate (HRmax). HRmax was estimated using the formula 220 minus age. Participants received real-time heart rate feedback and adjusted exercise intensity to remain within the target heart rate range. When heart rate was below the target range, participants increased movement amplitude and stepping cadence. When heart rate exceeded the target range, participants reduced movement amplitude and exercise pace until heart rate returned to the prescribed range. All exercise sessions were supervised by an instructor.
Interventions/Control_2
Participants in the COCO group consumed 100% cocoa powder at a dose of 0.17 g/kg/day for 8 weeks. The cocoa powder was mixed with 120 mL of water and consumed 30 minutes after dinner, without added milk or sugar. Before the intervention, participants completed a 1-week food diary to identify the use of other polyphenol-rich food supplements. Participants were instructed to maintain their dietary habits as closely as possible to those recorded in the food diary throughout the intervention period.
Interventions/Control_3
Control group
Participants were instructed to maintain their usual lifestyle during the 8-week study period and did not receive cocoa supplementation or the structured aerobic exercise intervention.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 55 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged 55-65 years middle-to-late adults; BMI < 30 kg/m2 (non-obese); middle-to-late adults who exercise less (exercising
fewer than 150 minutes per week of moderate activity);
Key exclusion criteria
Have cardiovascular disease and any kidney, lung, or metabolic disorders.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | wenbo |
| Middle name | |
| Last name | wang |
Organization
Universiti Malaya
Division name
Faculty of Sports and Exercise Science
Zip code
50603
Address
Faculty of Sports and Exercise Science, University Malaya, Kuala Lumpur 50603, Malaysia.
TEL
601133373980
wwb1794927210@gmail.com
Public contact
Name of contact person
| 1st name | wenbo |
| Middle name | |
| Last name | wang |
Organization
Universiti Malaya
Division name
Faculty of Sports and Exercise Science
Zip code
50603
Address
Faculty of Sports and Exercise Science, University Malaya, Kuala Lumpur 50603, Malaysia.
TEL
601133373980
Homepage URL
wwb1794927210@gmail.com
Sponsor or person
Institute
Universiti Malaya
Institute
Department
Personal name
wenbo wang
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universiti Malaya Research Ethics Committee
Address
Universiti Malaya, Lembah Pantai, 50603 Kuala Lumpur
Tel
6079672369
umrec@um.edu.my
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
The study protocol has not been publicly released.
Publication of results
Unpublished
Result
URL related to results and publications
The results have not yet been published.
Number of participants that the trial has enrolled
39
Results
Cocoa supplementation and cocoa plus aerobic exercise reduced baPWV compared with control after 8 weeks. The reduction was greater with cocoa plus exercise than with cocoa alone. SBP decreased in both intervention groups by week 8. No significant between-group differences were observed for DBP or resting heart rate.
Results date posted
| 2026 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 39 participants were enrolled and randomized into three groups (n = 13 per group): cocoa supplementation (COCO), cocoa supplementation combined with aerobic exercise (COEX), and control (CON). The participants were middle-aged and older adults with a mean age of 58.33+/-2.00 years and BMI < 30 kg/m2.
Participant flow
A total of 45 volunteers were recruited and screened, 39 were included in the study, and randomly allocated to a treatment group (13 received cocoa powder, 13 received a cocoa powder and aerobic exercise group, and 13 received the control group). Two volunteers withdrew during their first day due to the excessive bitterness of the cocoa powder, and four volunteers withdrew during their first week due to the inability to adhere to the exercise plan. Overall, 39 participants completed the study
Adverse events
No adverse events related to the interventions were reported during the study.
Outcome measures
Primary outcome: Brachial-ankle pulse wave velocity (baPWV) decreased over the 8-week intervention period. At week 8, baPWV was significantly lower in both the cocoa supplementation (COCO) and cocoa supplementation plus aerobic exercise (COEX) groups compared with the control group (CON). The reduction in baPWV was significantly greater in COEX than in COCO at week 8.
Secondary outcomes: Systolic blood pressure (SBP) decreased significantly in COEX at week 4 and was lower than in CON. At week 8, SBP was significantly reduced in both COCO and COEX compared with baseline, and both groups had lower SBP than CON. No significant between-group differences were observed for diastolic blood pressure (DBP) or resting heart rate (HR), although both decreased over time in COCO and COEX by week 8.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 07 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072346
