UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050377 |
|---|---|
| Receipt number | R000057357 |
| Scientific Title | Effects of intake of test foods on fatigue and malaise -Placebo-controlled, double-blind, parallel-group comparison study- |
| Date of disclosure of the study information | 2023/02/17 |
| Last modified on | 2023/10/19 13:15:53 |
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Basic information
Public title
Effects of intake of test foods on fatigue and malaise
Acronym
Effects of intake of test foods on fatigue and malaise
Scientific Title
Effects of intake of test foods on fatigue and malaise
-Placebo-controlled, double-blind, parallel-group comparison study-
Scientific Title:Acronym
Effects of intake of test foods on fatigue and malaise
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to verify that healthy subjects have experiences less fatigue and malaise in their daily lives on test foods for 12 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fatigue VAS
Key secondary outcomes
POMS2
OSA-MA
Acceleration pulse wave measurement (autonomic nervous system, etc.)
BDI-II
blood cortisol
DHEA-s
DHEA-s/blood cortisol ratio
neutrophil/lymphocyte ratio
fatigue (daily life log)
malaise (daily life log)
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food for 12 weeks
Interventions/Control_2
Daily intake of placebo(control food)for 12 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Persons who are judged by the investigator to be eligible to participate in the study.
(2) Persons with relatively poor fatigue VAS values.
(3) Persons who selected a response other than "I want to commit suicide" or "I intend to commit suicide if given a chance" in question 9 of the Physician Diagnosis and BDI-II Beck Depression Questionnaire.
(4) Persons who have signed a consent form prior to the start of the study upon full explanation of the purpose and content of the study.
Key exclusion criteria
(1) Persons who suffer from or have a history of serious heart disease, lung disease, gastrointestinal disease (esophagus, stomach, small intestine, large intestine, liver, kidney, etc.), hypertension, diabetes, malignant tumor, etc.
(2) Persons with food allergies or who may be allergic to the test food.
(3) Persons who regularly use licensed drugs or quasi-drugs that may affect the study.
(4) Persons who regularly use health foods (food for specified health uses, food with nutrient function claims, food with functional claims, supplements, etc.) that may affect the study.
(5) Persons who may be unable to discontinue the current drugs intake of pharmaceutical (excluding drugs used as needed), quasi-drugs, or health foods (food for specified health uses, food with nutrient function claims, food with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study.
(6) Persons who on work day and night shifts and those who are scheduled to work on night shift during the period of the study.
(7) Persons who are attending hospital for mental disorders (depression, etc.) or sleep disorders, or have a history of mental illness in the past.
(8) Persons whose drink more than 100 g of alcohol equivalent per week.
(9) Persons who drink alcohol more than 5 days per week.
(10) Persons who smoke more than 20 cigarettes per day.
(11) Persons who are participating in a clinical trial or have participated in another clinical trial within 3 months from the date of obtaining consent.
(12) Persons who plan to participate in other examinations during the study.
(13) Persons who may be unable to maintain their daily lifestyle (diet, exercise, alcohol consumption, smoking, etc.).
(14) Persons who have difficulty in intaking study food as directed.
(15) Persons who ones pregnant or breast feeding or planning to become pregnant during the study.
(16) Persons who are deemed inappropriate for this study by the investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Medical Corporation Watanabe Hospital
Division name
Director of the Watanabe Hospital
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Sakata |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Department Clinical Operations Division
Zip code
103-0027
Address
Front Place Nihonbashi,2-14-1,Nihonbashi,Chuo-ku,Tokyo,Japan
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
THERAVALUES CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Watanabe Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of the Medical Corporation Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
wnb.cto@gmail.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 渡辺病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 17 | 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
| 2023 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 29 | 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 | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057357
