UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038384 |
|---|---|
| Receipt number | R000043743 |
| Scientific Title | Study for Anti-fatigue effect of chocolate |
| Date of disclosure of the study information | 2019/10/28 |
| Last modified on | 2020/04/02 15:11:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study for Anti-fatigue effect of chocolate
Acronym
Study for Anti-fatigue effect of chocolate
Scientific Title
Study for Anti-fatigue effect of chocolate
Scientific Title:Acronym
Study for Anti-fatigue effect of chocolate
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the fatigue-reducing effect of chocolate intake on fatigue caused by mental workload.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Fatigue evaluation
-Saliva test
-Calculation task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of chocolate and water
Washout for 1day or more
Intake of water
Interventions/Control_2
Intake of water
Washout for 1day or more
Intake of chocolate and water
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
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Persons who are 20 years old or more and under 65 years old, Male and Female
Key exclusion criteria
1. Persons who have chronic illness, receiving medication
2. Persons who are allergic to rice, cacao, milk ingredient and soy
3. Persons who are unable to ingest high cacao chocolate
4. Persons who have participated in other tests (Excluding observational research) within the first month before the start of the exam, or who are planning to participate in other tests from after this exam consent to the end of this exam
5. Persons who are breast-feeding, pregnant, and are planning pregnancy during the exam
6. Persons who are judged ineligible at the discretion of the principal investigator and sub-investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Natsume |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology and Function Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
TEL
042-632-5850
midori.natsume@meiji.com
Public contact
Name of contact person
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
ishikawa@hc-sys.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Healthcare Systems Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
| 2019 | Year | 10 | Month | 28 | 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
29
Results
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
| 2019 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043743
