UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049097 |
|---|---|
| Receipt number | R000055931 |
| Scientific Title | Effects of consumption of the test food on subjective fatigue in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, crossover comparison trial |
| Date of disclosure of the study information | 2023/12/27 |
| Last modified on | 2023/03/29 13:05:32 |
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Basic information
Public title
Effects of consumption of the test food on subjective fatigue in healthy Japanese subjects
Acronym
Effects of consumption of the test food on subjective fatigue in healthy Japanese subjects
Scientific Title
Effects of consumption of the test food on subjective fatigue in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, crossover comparison trial
Scientific Title:Acronym
Effects of consumption of the test food on subjective fatigue in healthy Japanese subjects
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 consumption of the test food on temporary subjective fatigue in healthy Japanese subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Momentary subjective fatigue level of subjects measured by visual analogue scale (VAS) after the workload
2. Momentary subjective fatigue level of subjects measured by VAS before the workload
Key secondary outcomes
1. Subjective symptoms measured by VAS
2. Salivary markers
3. Heart rate
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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: Single ingestion (two test periods)
Test food:
<Active food> Active tablet
<Placebo food>Placebo tablet
Administration:
After completing the pre-consumption examination, take one active tablet with a drink such as water in period I. After washout period, take one placebo tablet with a drink such as water in period II
Interventions/Control_2
Duration: Single ingestion (two test periods)
Test food:
<Active food> Active tablet
<Placebo food>Placebo tablet
Administration:
After completing the pre-consumption examination, take one placebo tablet with a drink such as water in period I. After washout period, take one active tablet with a drink such as water in period II
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Subjects aged 20 or more and less than 65
4. Healthy subjects
5. Subjects who easily feel fatigue due to work such as office work
6. Subjects whose subjective fatigue measured by VAS is 40 mm or more
Key exclusion criteria
Subjects who / whose
1.are undergoing medical treatment or have a medical history of malignancy, heart failure, and myocardial infarction
2.anthropometric measurements, physical examination values, or laboratory values are D or above in the criteria category of the Japan Society of Ningen Dock
3.have a medical history of cardiopathy, a pacemaker, or an implantable cardioverter defibrillator
4.have treatment for chronic disease such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension
5.are going a psychiatric medical institute / meet the criteria for a major depressive episode
6.are going a hospital / receive treatment / take medicines or health food to improve sleep or stress
7.usually take "Foods for Specified Health Uses," or "Foods with Functional Claims"
8.have a disease with constant medication / have a medical history of malignancy with medication (except for remission)
9.usually take medicines (including herbal medicines) and supplements
10.habitually take an energy drink once weekly or more
11.are allergic to medicines and/or the test food related products
12.work in late-night / sleep between 6 and 10 AM and get up between 6 and 8 PM once weekly or more
13.work in physical labor
14.have hormonal treatment / are diagnosed with menopausal syndrome by a doctor
15.are diagnosed with arrhythmia by a doctor
16.smoke / stopped smoking within one year before screening
17.usually drink more than an appropriate amount (about 20 g/day as absolute alcohol)
18.are pregnant, lactating, or planning to become pregnant during this trial
19.suffer from COVID-19 / are a close contact person
20.have been enrolled in other clinical trials within the last 28 days before the agreement to participate or plan to participate another trial during this trial
21.are judged from the interview to have difficulty receiving prescribed examination or complying with the restrictions
22.are judged as ineligible by the physician
Target sample size
36
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
KAMEDA SEIKA CO., LTD.
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 Building, 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 | 27 | 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
| 2022 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 28 | 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 | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055931
