UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053231 |
|---|---|
| Receipt number | R000060745 |
| Scientific Title | An examination study of the anti-stress effect by the test food consumption: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/12/26 |
| Last modified on | 2024/08/01 16:31:51 |
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Basic information
Public title
An examination study of the anti-stress effect by the test food consumption
Acronym
An examination study of the anti-stress effect by the test food consumption
Scientific Title
An examination study of the anti-stress effect by the test food consumption: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
An examination study of the anti-stress effect by the test food consumption
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the anti-stress effect of consumption of the test food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F) in the Profile of Mood States 2nd Edition (POMS2) at four weeks after consumption (4w)
Key secondary outcomes
1. Each item in the POMS2 at 4w
2. "Sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA sleep inventory MA version (OSA-MA) at 4w
3. Total score in the Athens Insomnia Scale (AIS) at 4w
4. Each item in the AIS at 4w
5. The measured values of salivary cortisol at 4w
6. The gut microbiota, intestinal metabolites, blood metabolites, and blood hormone at 4w
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
Test food: Powdered food 1
Interventions/Control_2
Duration: Four weeks
Test food: Powdered food 2
Interventions/Control_3
Duration: Four weeks
Test food: Placebo food
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged 30 or more and less than 60
4. Healthy individuals
5. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck depression inventory (BDI-II) at screening
6. Individuals whose Total Mood Disturbance (TMD) score in the Profile of Mood States 2nd Edition (POMS2) is high among those who meet inclusion criteria No.1~5 without meeting any of exclusion criteria
Key exclusion criteria
Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are currently undergoing medical treatment or have a medical history of insomnia or sleep disorder
5. are currently undergoing medical treatment or have a medical history of psychiatric disorder such as depression disorder
6. are currently undergoing medical treatment or have a medical history of chronic fatigue syndrome
7. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
8. are taking medications, "Foods for Specified Health Uses," "Foods with Functional Claims," or supplements which may affect fatigue or sleep
9. are taking medications (including herbal medicines) and supplements
10. are allergic to medicines and/or the test food related products
11. are pregnant, lactating, or planning to become pregnant during this study
12. sleep with more than one person
13. have irregular sleeping time or habit due to work such as a late-night shift
14. need to get up in the middle of the night for childcare or nursing care
15. have irregular lifestyles (such as not working full-time, not eating meals at regular intervals, or not sleeping enough)
16. usually drink to excess (average of more than about 20 g/day as absolute alcohol intake)
17. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
18. are judged as ineligible to participate in this study by the physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
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
Combi Corporation.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi 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 Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 26 | 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
36
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 | 12 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 26 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060745
