UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048949 |
|---|---|
| Receipt number | R000055681 |
| Scientific Title | Study of effects of test product on mental stress in healthy adults. -A randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2022/09/20 |
| Last modified on | 2023/11/21 16:07:50 |
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Basic information
Public title
Study of effects of test product on mental stress in healthy adults. -A randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
Study of effects of test product on mental stress in healthy adults.
Scientific Title
Study of effects of test product on mental stress in healthy adults. -A randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
Study of effects of test product on mental stress in healthy adults.
Region
| Japan |
Condition
Condition
None(Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of test product intake on mental stress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary cortisol
Key secondary outcomes
Subjective evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intakes of test product for 8 days
Interventions/Control_2
Intakes of placebo product for 8 days
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged between 20 and 60 at the time of obtaining consent to participate in the study.
(2) Those who are judged to be healthy by the investigator and who do not have chronic physical illness.
(3) Those who are prone to fatigue in daily life.
(4) Those who feel stress, blush, heartbeat, etc. when speaking in front of people
(5) Those who can come to the office on the designated inspection date and undergo inspection.
(6) Those who have received sufficient explanation about the purpose and contents of this study, have the ability to consent, voluntarily apply for participation after understanding it well, and can consent to participate in this study in writing.
(7) Those who the investigator deems appropriate to participate in this study.
Key exclusion criteria
(1) Those who are receiving drug treatment, or regularly use drugs for purposes other than treating the disease.
(2) Those who are suffering from, are undergoing treatment, or have a history of serious diseases such as diabetes, kidney/liver disease, heart disease, thyroid disease, adrenal disease, or other metabolic diseases.
(3) Those who are undergoing treatment for psychological stress and using related or test product ingredient-containing medicines, supplements, and health foods.
(4) Those who regularly take antihistamines.
(5) Those who have been diagnosed with dry mouth or have subjective symptoms of it.
(6) Those who have a score of 16 or higher on the Quick Inventory of Depressive Symptomatology.
(7) Those who have been diagnosed with chronic fatigue syndrome, or are judged by the investigator or coordinator to have severe fatigue
(8) Those who have a history of drug dependence, alcohol dependence, or their current medical history.
(9) Those who may be allergic to the ingredients contained in the test food, and those who may be serious allergic to other foods and pharmaceuticals.
(10) Persons with severe anemia.
(11) Persons with BMI of less than 18.5 or more than 25 kg/m2.
(12) Those who are expected to have a life event that is expected to have a significant psychological impact during the study period or have occurred.
(13) Those who have a profession or experience in speaking in public.
(14) Those who work for a company that develops, manufactures, and sells functional foods.
(15) Smokers
(16) Persons who cannot sleep at night due to irregular work or other reasons.
(17) Those who are participating in or willing to participate in the study of ingesting foods, using drugs, applying cosmetics and drugs during this study period.
(18) Those who are currently breastfeeding, are pregnant and may be pregnant, or are willing to become pregnant during the study period.
(19) Others who are judged by the investigator to be unsuitable as subjects.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Morita |
Organization
Kirin Holdings Company, Limited
Division name
Research & Development division, Kirin Central Research Institute
Zip code
251-0012
Address
Shonan Health Innovation Park, 2-26-1, Muraoka-Higashi, Fujisawa, Kanagawa, Japan
TEL
090-3063-2127
Masahiko_Morita@kirin.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co. Ltd
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku building, 2-7-5, Higashiueno Taito-ku, Tokyo, 110- 0015 Japan
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
Kirin Holdings Company, Limited
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethical Review Committee of Kirin Holdings Company, Ltd.
Address
Nakano Central Park South, 4-10-2, Nakano, Nakano-ku, Tokyo, Japan
Tel
03-6837-4128
02976_Ni@kirin.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
うえのあさがおクリニック（東京都） Ueno Asagao Clinic (Tokyo)
TKP市ヶ谷カンファレンスセンター（東京都） TKP Ichigaya Conference Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 20 | 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
| 2022 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055681
