UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052419 |
|---|---|
| Receipt number | R000059834 |
| Scientific Title | A placebo-controlled, single blind, two-period crossover, comparative superiority clinical trial concerning the effect on cerebral function by taking test beverage. |
| Date of disclosure of the study information | 2023/10/11 |
| Last modified on | 2024/02/16 09:22:07 |
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Basic information
Public title
A placebo-controlled, two-period crossover clinical trial concerning the effect on cerebral function by taking test beverage.
Acronym
A placebo-controlled, two-period crossover clinical trial concerning the effect on cerebral function by taking test beverage.
Scientific Title
A placebo-controlled, single blind, two-period crossover, comparative superiority clinical trial concerning the effect on cerebral function by taking test beverage.
Scientific Title:Acronym
A placebo-controlled, single blind, two-period crossover, comparative superiority clinical trial concerning the effect on cerebral function by taking test beverage.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on cerebral function by taking test beverage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fMRI
Key secondary outcomes
Questionnaire concerning psychological evaluation
pulse rate
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
Take 200 mL test food sitting at rest taking 5 minutes
Interventions/Control_2
Take 200 mL placebo food sitting at rest taking 5 minutes
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
| 36 | years-old | > |
Gender
Male
Key inclusion criteria
1. Healthy male adults aged between 20 and 35
2. BMI less than 25.0 kg/m^2
3. No smoker (No smoking past one year)
4. Received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent
Key exclusion criteria
1.Receiving continuous pharmaceutical treatment with drugs including commercial pharmaceuticals and Chinese medicines excluding use as needed
2.Receiving any dietary or exercise treatment under medical doctors
3.Current or a history of mental disease, sleep disorder, hypertension, diabetes, dyslipidemia, or serious illness
4.Current or a history of serious disorders of the liver, kidneys, heart, lungs, blood
5.A gastrointestinal comorbidity or serious medical history
6.Using implanted medical devices containing pacemakers or blood vessel clips
7.A habit of taking drugs for treating diseases in past one month, excluding use of drugs for headaches, colds
8.Have been taking foods with functional health claims that affect autonomic nervous system, metabolism and sleep, excluding who can quit intake during the study
9.A constitutional difficulty in drinking alcohol
10.At risk of developing hay fever or seasonal allergy symptoms or have allergic rhinitis during the study period.
11.Have or at risk of developing drug or food allergy symptoms
12.Have difficulty wearing a heart rate monitor, such as an allergy to tape
13.Alcohol drinkers, over 40 g/day of alcohol
14.Extremely irregular eating habits
15.Shift workers
16.Under significant stress of any life event within 3 months before IC, or will have such a life event during the study period
17.Have participated another clinical study within 1 month before IC, or will participate in it during the study period or within 1 month after the end of the study
18.Cannot quit drinking from the day before the test date
19.Have claustrophobia
20.Current or a history of mental disorder containing depression
21.A history of head surgery
22.Using electrical nerve stimulation devices
23.Have any tattoos
24.Have metal fragments in their body
25.Undergoing implant treatment
26.Wearing orthodontic bridges
27.Severe visual impairment, taste impairment, or olfactory impairment
28.Unsuitable for the study judged by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Fumiya |
| Middle name | |
| Last name | Nakamura |
Organization
ASAHI QUALITY & INNOVATIONS, LTD.
Division name
Core Technology Laboratories
Zip code
302-0106
Address
1-21, Midori 1-Chome, Moriya-Shi, Ibaraki, Japan
TEL
080-7789-1040
Fumiya.nakamura@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
sales-contact@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
ASAHI QUALITY & INNOVATIONS, 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.co.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 | 11 | 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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059834
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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