UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052671 |
|---|---|
| Receipt number | R000060106 |
| Scientific Title | Effects of consumption of the test food on fatigue: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/07/01 10:58:24 |
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Basic information
Public title
Effects of consumption of the test food on fatigue
Acronym
Effects of consumption of the test food on fatigue
Scientific Title
Effects of consumption of the test food on fatigue: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on fatigue
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 effects of consumption of the test food on fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured values of total score in the Chalder Fatigue Scale (CFS) and subjective fatigue measured by visual analogue scale (VAS) at eight weeks after consumption (8w)
Key secondary outcomes
1. The measured values of total score in the CFS and subjective fatigue measured by VAS at four weeks after consumption (4w)
2. The changes from screening (before consumption) of total score in the CFS and subjective fatigue measured by VAS at 4w and 8w
3. The changes from 4w of total score in the CFS and subjective fatigue measured by VAS at 8w
4. The measured values of physical fatigue score, mental fatigue score in the CFS, "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), and total score in the Athens Insomnia Scale (AIS) at 4w and 8w
5. The measured values of total score in the Japanese version of the Center for Epidemiologic Studies Depression Scale (CES-D), 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 Japanese version of the Profile of Mood States 2nd Edition (POMS2), flicker value (average of both eyes), high frequency (HF), low frequency (LF), LF/HF ratio, Total Power, glutathione peroxidase activity, superoxide dismutase (SOD) activity, diacron-reactive oxygen metabolites (d-ROMs), biological antioxidant potential (BAP), BAP/d-ROMs ratio, lipid peroxide, blood antioxidant capacity analysis by the multiple free-radical scavenging (MULTIS) method, urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG), urinary homovanillic acid, urinary vanillylmandelic acid, salivary cortisol, salivary secretory immunoglobulin A (s-IgA), and each item in the original questionnaire about facial skin at 8w
6. Each item in the POMS2 at 8w
7. Each item in the AIS and each item in the CFS at 4w and 8w
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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: Eight weeks
Test food: Active food
Administration: Take one serving per day.
Interventions/Control_2
Duration: Eight weeks
Test food: Placebo food
Administration: Take one serving per 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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged 20 or more and less than 50
4. Healthy individuals
5. Individuals whose total score in the CFS is 16 or more
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
3. are currently undergoing treatment for any of the following chronic diseases: cardiovascular disease, cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are undergoing medical treatment or have a medical history of chronic fatigue syndrome
5. have been diagnosed with psychiatric disorder and are undergoing treatment
6. have score of the Center for Epidemiologic Studies Depression Scale is 16 or more
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. have menoxenia (women only)
13. have bleeding teeth or oral problems (gingivitis, dry mouth, stomatitis, etc.)
14. have undergone or plan to undergo dental, or oral treatment {treatment of dental decay, periodontal disease, or others, including periodic scaling (dental cleaning)} within one month prior to the screening (before consumption) and during this study
15. answered "have smoked cigarettes daily or occasionally within the last month" among those who have habitually smoked cigarettes in the past
16. 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
17. are judged as ineligible to participate in this study by the physician
Target sample size
60
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
Mizkan Holdings 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 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 | 11 | Month | 01 | 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
64
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 | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 17 | 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 | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060106
