UMIN-CTR Clinical Trial

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
Email	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
Email	mf21039@shibaura-it.ac.jp

Sponsor
Institute	Shibaura institute of technology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052641