UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029028 |
|---|---|
| Receipt number | R000033204 |
| Scientific Title | Improvement of brain function due to long-term chocolate intake. |
| Date of disclosure of the study information | 2017/09/06 |
| Last modified on | 2019/12/09 10:44:34 |
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Basic information
Public title
Improvement of brain function due to long-term chocolate intake.
Acronym
Chocolate intake and brain function
Scientific Title
Improvement of brain function due to long-term chocolate intake.
Scientific Title:Acronym
Chocolate intake and brain function
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of long-term administration of chocolate on human cognitive functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stroop color word test
Key secondary outcomes
1) Cerebral blood flow
2) Blood composition
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of dark chocolate (4 weeks)
24 g/day (135 kcal/day)
Interventions/Control_2
Oral intake of white chocolate (4 weeks)
24.5 g/day (145 kcal/day)
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Those who are more than 20 years old.
2)Those who agreed to participate in research.
3)Those who have no health problems.
Key exclusion criteria
1)Those who have a smoking habit.
2)Those who intake caffeine more than 400 mg per day.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eri Sumiyoshi |
Organization
Shimane University
Division name
Faculty of Medicine
Zip code
Address
89-1 Enya cho Izumo city 693-8501
TEL
0853-20-2114
erisumi@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Tanabe |
Organization
Shimane University
Division name
Faculty of Medicine
Zip code
Address
89-1 Enya cho Izumo city 693-8501
TEL
0853-20-2113
Homepage URL
tanabey@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 09 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/31744119
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/31744119
Number of participants that the trial has enrolled
20
Results
DC intake significantly increased the score of the SCWT and the D-CAT at Post compared with those at Pre. At 3 weeks after the end of the intervention (FU), the score of these tests remained at a higher level than those at Pre. However, WC intake group did not change throughout the intervention period. For the DC group, the level of Nerve Growth Factor (NGF) was increased at Post and returned to baseline at FU. However, WC intake group did not change throughout the intervention period.
Results date posted
| 2019 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 11 | Month | 14 | Day |
Baseline Characteristics
Healthy young subjects (14 men and 6 women, ages 20-31 years old) were recruited from Japanese undergraduate students.
Subjects were screened for the following inclusion criteria: nonsmokers, not medicated, and without obvious clinical symptoms and problems, such as hypertension, diabetes, and gastrointestinal disorders.
Participant flow
Each subject provided written and informed consent after all procedures and potential risks were explained.
Subjects took chocolate (dark or white) daily for 30 days (Chocolate intake intervention). The subjects' physical characteristics, cognitive function test, and PFCBF were recorded pre (Pre) and post intervention (Post) and at a follow up (FU) visit, 3 weeks after the end of the intervention. Blood was sampled before chocolate intake (Baseline), during the chocolate intake intervention (1, 2, 3 and 4 weeks) and FU.
Adverse events
Not applicable.
Outcome measures
The primary outcomes were improvement of cognitive function by dark chocolate ingestion,estimated using the paper version of the SCWT (modified SCWT) and the D-CAT. Secondary outcome was elevated neurotrophin concentration in the plasma.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 06 | Day |
Last modified on
| 2019 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033204
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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