UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026486 |
|---|---|
| Receipt number | R000030420 |
| Scientific Title | The effect of regular high cacao-content chocolate ingestion on arterial stiffness and metabolic responses in exercise. |
| Date of disclosure of the study information | 2017/03/27 |
| Last modified on | 2020/12/24 11:34:18 |
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Basic information
Public title
The effect of regular high cacao-content chocolate ingestion on arterial stiffness and metabolic responses in exercise.
Acronym
The effect of high cacao-content chocolate.
Scientific Title
The effect of regular high cacao-content chocolate ingestion on arterial stiffness and metabolic responses in exercise.
Scientific Title:Acronym
The effect of high cacao-content chocolate.
Region
| Japan |
Condition
Condition
Healthy young adult population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of regular high cacao-content chocolate ingestion on arterial stiffness and metabolic responses in exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial stiffness (after 4 week)
Key secondary outcomes
Respiratory gas responses in exercise (after 4 week)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
No treatment, 4 week
Interventions/Control_2
High cacao-content chocolate ingestion (20 g/day), 4 week
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years and older men and women, not restricted by a doctor from exercising, not have medication and smoking.
Key exclusion criteria
Have a cardiovascular and cerebrovascular disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nishiwaki |
Organization
Osaka Institute of Technology
Division name
Faculty of Engineering
Zip code
535-8585
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
TEL
06-6954-4391
masato.nishiwaki@oit.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Nishiwaki |
Organization
Osaka Institute of Technology
Division name
Faculty of Engineering
Zip code
535-8585
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
TEL
06-6954-4391
Homepage URL
masato.nishiwaki@oit.ac.jp
Sponsor or person
Institute
Faculty of Engineering, Osaka Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka Institute of Technology
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
Tel
06-6954-4391
masato.nishiwaki@oit.ac.jp
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
| 2017 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0899900718309419?via%3Dihub
Number of participants that the trial has enrolled
Results
First, we examined the effects of ingesting high-cacao chocolate on arterial stiffness in young healthy men. After 4 weeks of ingestion, arterial stiffness did not change in the Control group. However, arterial stiffness significantly reduced in the Intervention group.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 24 | Day |
Other
Other related information
Second, we examined the effects of ingesting high-cacao chocolate on metabolic characteristics during exercise in young healthy people. After 4 weeks of ingestion, metabolic characteristics during exercise did not change in both groups.
Management information
Registered date
| 2017 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030420
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
