UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052574 |
|---|---|
| Receipt number | R000059991 |
| Scientific Title | A study to evaluate the effects of food ingredients on brain function |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2024/04/16 10:58:05 |
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Basic information
Public title
A study to evaluate the effects of food ingredients on brain function
Acronym
A study to evaluate the effects of food ingredients on brain function
Scientific Title
A study to evaluate the effects of food ingredients on brain function
Scientific Title:Acronym
A study to evaluate the effects of food ingredients on brain function
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the test beverage on brain function in Japanese men aged 20 years or older and 35 years or younger.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fMRI
Key secondary outcomes
(Secondary outcomes)
Questionnaire concerning psychological evaluation
pulse rate
(Safety evaluation)
adverse events
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake placebo beverage on the day
Washout
Intake test beverage on the day
Interventions/Control_2
Intake test beverage on the day
Washout
Intake placebo beverage on the 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
Key inclusion criteria
1.Healthy Japanese males who are between 20 and 35 years of age at the time of written informed consent.
2.BMI less than 25.0 kg/m2.
3.No smoker (No smoking past one year).
4.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Key exclusion criteria
1.Receiving continuous pharmaceutical treatment with drugs including commercial pharmaceuticals and Chinese medicines due to some kind of illness 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 dismissal history of drugs for headaches, colds.
8.Have been taking any products (e.g., foods for specified health use, foods with functional health claims , health foods, drugs, quasi-drugs) 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 (such as bandage).
13.Alcohol drinkers, over 60 g/day of alcohol on daily basis.
14.Extremely irregular eating habits.
15.Night workers or 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.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
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
Miyake Clinic Institutional Review Board
Address
4-2-17 Komagome, Toshima-ku, Tokyo 170-0003 Japan
Tel
03-6903-7211
jim@medipharma.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 | 23 | 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
40
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 | 10 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 22 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 22 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 09 | Day |
Other
Other related information
(Exclusion criteria continued)
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.
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059991
