UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038135 |
|---|---|
| Receipt number | R000043463 |
| Scientific Title | A study to evaluate the effects of test food on autonomic nerve activity: a randomized, double-blind, placebo-controlled, crossover trial |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2020/07/29 12:08:18 |
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Basic information
Public title
A study to evaluate the effects of test food on autonomic nerve activity: a randomized, double-blind, placebo-controlled, crossover trial
Acronym
A study to evaluate the effects of test food on autonomic nerve activity
Scientific Title
A study to evaluate the effects of test food on autonomic nerve activity: a randomized, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym
A study to evaluate the effects of test food on autonomic nerve activity
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food on autonomic nerve activity in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Heart rate variability
Key secondary outcomes
Neuropsychological tests for cognitive functions
Visual Analogue Scale (VAS) of fatigue
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Period I. the test food
Period II. control food
* The intervention sequence is Period I to II.
* Washout period is for approximately 1 week.
Interventions/Control_2
Period I. control food
Period II. the test food
* The intervention sequence is Period I to II.
* Washout period is for approximately 1 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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects who use Japanese as his/her primary language
2.Subjects who are judged as healthy by the physician from screening (scr) test
Key exclusion criteria
Subjects who
1. cannot identify color
2. have difficulty taking cognitive function tests because of weak sight or hearing
3. have 26 scores or less of MMSE
4. have a symptom, have been diagnosed, have a history, and/or have a daily medication for the following items: amblyopia, blindness, deafness, anacusis, cerebral nervous disease, cardiac disorder, depressive symptoms, depression, menopausal syndrome, sleep-related diseases, cardiac arrhythmia, and/or serious disease
5. are receiving hormonal therapy, or treatment related to cognitive function
6. have a pacemaker
7. sometimes have irregular lifestyles during study
8. have the following situation more than once a week: [taking drugs, or health foods that influence cognitive function, autonomic nerve activity, or improving sleep], or [taking foods resembling test food or energy drink]
9. having a habit of drinking beverages relating test foods more than once a month, regardless of amount, or cannot abstain from drinking the beverages between 1 week before scr test and the end of the test period
10. regularly drink alcohol beyond proper quantity
11. are smokers, or started smoking cessation within the last 12 months before scr
12. have experienced cognitive function tests within the last 12 months before scr
13. have donated whole blood or got a blood transfusion within the last 3 months before scr
14. have been enrolled in other clinical trials within the last 1 month before scr, or planning to participate during the test period
15. have a risk of allergies to the test food
16. are pregnant or lactation
17. are judged inappropriate as subjects from answers to lifestyle questionnaires
18. are not successfully taken his/her data of autonomic nerve activity at scr
19. or whose family who living together work at a company developing and manufacturing functional foods
20. plan to do the following during the test period: go abroad, donate blood, pregnant or lactation
21. are judged as unsuitable by doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 30 | 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
34
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
| 2019 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043463
