UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052507 |
|---|---|
| Receipt number | R000059922 |
| Scientific Title | Examination of the antifatigue effect iuduced by the cacao polyphenol of chocolate |
| Date of disclosure of the study information | 2023/10/17 |
| Last modified on | 2024/10/16 09:10:42 |
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Basic information
Public title
Examination of the antifatigue effect of the cacao ingredient in the commercial chocolate
Acronym
Examination of the antifatigue effect of chocolate
Scientific Title
Examination of the antifatigue effect iuduced by the cacao polyphenol of chocolate
Scientific Title:Acronym
Examination of the cacao polyphenol's antifatigue effect
Region
| Japan |
Condition
Condition
Healthy Adult/Fatigue
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate whether fatigue before and after the learning of healthy adult is mitigated by the intake of cacao polyphenol in chocolate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this experiment, physical examinations: subjective fatigue degree, blood pressure, pulse and flicker level of the examinees are measured, before the intake of chocolate. The examinees take in chocolate before learning start. After one hour learning, the same physical examinations of examinees are measured. After 30 minutes later, the same physical examinations are measured again. The examinees take two types of chocolate with different content of cacao polyphenol and perform two times of similar experiments. In this study, comparing the differences of fatigue level in each experiment, the influence of cacao polyphenol of chocolate is analyzed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Before one hour learning, the examinees take two pieces of chocolate which is 4.65 g and contains 59mg cacao polyphenol per one piece.
Interventions/Control_2
Before one hour learning, the examinees take two pieces of chocolate which is 4.65 g and contains 32mg cacao polyphenol per one piece.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The healthy adult examinees who can take chocolate and perform one-hour learning action are targeted.
Key exclusion criteria
The examinees who cannot take in chocolate or have an allergy to chocolate and cacao are excluded.
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Nishida |
Organization
Tezukayama University
Division name
Faculyty of Comtemporary Human Life Science
Zip code
6318585
Address
3-1-3 Gakuenminami Nara City Japan
TEL
0742880004
s-nishida@tezukayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Nishida |
Organization
Tezumakaya University
Division name
Faculyty of Comtemporary Human Life Science
Zip code
6318585
Address
3-1-3 Gakuenminami Nara City Japan
TEL
0742880004
Homepage URL
s-nishida@tezukayama-u.ac.jp
Sponsor or person
Institute
Tezukayama University
Institute
Department
Personal name
Seiichiro Nishida
Funding Source
Organization
Tezukayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tezumakaya University
Address
3-1-3 Gakuenminami Nara City Japan
Tel
0742880004
s-nishida@tezukayama-u.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
| 2023 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
Results
A total of seven people participated. Milk chocolate suppressed the increase in subjective fatigue (VAS) after the learning task and also showed a greater degree of recovery. Regarding objective fatigue measured by flicker value, dark chocolate suppressed the increase in fatigue with a significant difference. Recovery of fatigue after a break was greater with milk chocolate, but final overall improvement in fatigue was greater with dark chocolate.
Results date posted
| 2024 | Year | 10 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Not particular
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059922
