UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046120 |
|---|---|
| Receipt number | R000052641 |
| Scientific Title | Improvement of cognitive function by ingestion of cacao flavanol : Double-blind crossover test |
| Date of disclosure of the study information | 2021/11/21 |
| Last modified on | 2022/05/27 16:15:00 |
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Basic information
Public title
Improvement of cognitive function by ingestion of cacao flavanol
Acronym
Cacao flavanol test
Scientific Title
Improvement of cognitive function by ingestion of cacao flavanol :
Double-blind crossover test
Scientific Title:Acronym
Cacao flavanol test:
Double-blind crossover test
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of cocoa flavanol intake on cognitive function.
Specifically, the effects on cognitive function of consuming a beverage containing cocoa polyphenols (30 to 120 mg as flavanols) per serving of the test food will be examined in a double-blind crossover study in healthy men and women aged 40 to 65 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy endpoint:
Cognitive function test by Cognitrax
Safety evaluation:
Interview of physical condition after the exam
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Cocoa drink
The test food, a beverage containing cocoa polyphenols (30-120 mg as flavanols) per serving, will be consumed. The period of intake is two days with an interval of one week.
Interventions/Control_2
placebo drink
The test food, a beverage without cocoa polyphenols (0 mg as flavanols) per serving, will be consumed. The period of intake is two days with an interval of one 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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Men and women between 40 and 65 years of age at the time of obtaining consent to participate in the study
2.Healthy and free from chronic physical diseases
3.Those who have received sufficient explanation of the purpose and content of the study, are capable of consenting, understand the study well, and voluntarily volunteer to participate, and can agree to participate in the study in writing.
4.Those who are able to come to the site on the designated measurement date and undergo the measurement.
5.Those who have been approved by the study physician to participate in the study.
Key exclusion criteria
1.Those who currently suffer from any kind of disease and are undergoing drug treatment
2.Those who have or are being treated for symptoms of dementia or other memory disorder diseases.
3.Those who have been taking medication for the purpose of disease treatment in the past month (excluding history of headache, menstrual cramps, common cold, etc.)
4.Those who have a history of or are currently suffering from serious disorders of the liver, kidney, heart, lungs, blood, etc.
5.Those with comorbidities or history of comorbidities in the digestive organs
6.Patients with severe anemia
7.Those with food allergies (especially milk)
8.Women: Pregnant, lactating, or planning to become pregnant during the study period
9.Persons with alcoholism or other mental disorders
10.Those with a smoking habit
11.Those who may change their lifestyle during the study period
12.Those at risk of developing seasonal allergic symptoms such as hay fever during the test period.
13.Those who have been in the habit of taking functional foods, health foods, or supplements containing the ingredients (polyphenols) of the test foods at present or within the past three months, and those who plan to do so during the test period.
14.Those who have been in the habit of taking drugs, functional foods, health foods, or supplements claiming to have cognitive effects at present or within the past three months.
15.Have received hormone replacement therapy within the past 6 months.
16.Those who have been treated with hospitalization within the past 6 months, or those who are scheduled to be hospitalized during the examination period.
17.Those who are currently participating in other human clinical trials, and those who have been participating in other human clinical trials for less than one month.
18.Those who have not yet completed the second dose of COVID-19 vaccine.
19.Others who are judged by the investigator to be inappropriate for this study.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Sato |
Organization
Shibaura institute of technology
Division name
College of Systems Engineering and Science, Bioscience and Engineering, Applied Brain Science laboratory
Zip code
337-8570
Address
307 Fukasaku, Minuma Ward, Saitama City, Saitama Prefecture Building 6, 6104
TEL
048-720-6016
hiroki@shibaura-it.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Konno |
Organization
Shibaura institute of technology
Division name
Systems Engineering and Science, Applied Brain Science laboratory
Zip code
337-8570
Address
307 Fukasaku, Minuma Ward, Saitama City, Saitama Prefecture Building 6, 6104
TEL
048-720-6016
Homepage URL
mf21039@shibaura-it.ac.jp
Sponsor or person
Institute
Shibaura institute of technology
Institute
Department
Personal name
Funding Source
Organization
MORINAGA&CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Incorporated Association Crinical Research Review Center
Address
2972-8-603 Ishikawamachi Hachioji-shi, Tokyo, 192-0032, JAPAN
Tel
0426-48-4368
crrctakashima@kpd.biglobe.ne.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
株式会社セブンオーワンリサーチ
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 21 | 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
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 19 | Day |
Last modified on
| 2022 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052641
