UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055251 |
|---|---|
| Receipt number | R000062713 |
| Scientific Title | Study on the Effect of Consumption of Test Foods on the Sensation of Fatigue |
| Date of disclosure of the study information | 2024/08/16 |
| Last modified on | 2024/10/04 14:48:41 |
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Basic information
Public title
Study on the Effect of Consumption of Test Foods on the Sensation of Fatigue
Acronym
Study on the Effect of Consumption of Test Foods on the Sensation of Fatigue
Scientific Title
Study on the Effect of Consumption of Test Foods on the Sensation of Fatigue
Scientific Title:Acronym
Study on the Effect of Consumption of Test Foods on the Sensation of Fatigue
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of four consecutive weeks of consumption of the test food on the feeling of fatigue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue-related indicators
(Week 0, Week 2, Week 4)
Key secondary outcomes
*Secondary indexes
1) Autonomic Nervous System Measurement (1)
2) Stress-related indicators in saliva (1)
*Safety
1) Physical examinations (1)
2) Clinical examinations (2)
3) Doctor's questions / Adverse events (1)
4) Subject's diary (3)
(1): Week 0, Week 2, Week 4
(2): Week 0, Week 4
(3): From the first day of ingestion of a test material to the last day of the test
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (1 bottle in a day; 4 weeks)
Interventions/Control_2
Oral intake of the placebo food (1 bottle in a day; 4 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 20 and 65 years of age at the time of obtaining consent to participate in the study.
2) Standard Japanese who are healthy and free from chronic physical diseases.
3) Individuals with physical or mental fatigue on a daily basis.
4) Individuals whose written informed consent has been obtained.
5) Individuals who can come to the designated venue for this study and be inspected.
6) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals with chronic fatigue.
2) Individuals using medical products.
3) Individuals with a history or current history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness.
4) Individuals with a serious history of liver, kidney, heart, lung, blood, etc.
5) Individuals with co-morbidities and serious history of gastrointestinal diseases.
6) Individuals who used a drug to treat a disease in the past 1 month.
7) Individuals whose BMI is over 30 kg/m2.
8) Individuals who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug.
9) Alcoholics or those whose daily alcohol consumption exceeds an average weekly alcohol equivalent of 60 g/day.
10) Individuals with possible changes of life style during the test period.
11) Individuals who have been taking functional foods, health foods, supplements, etc. on a continuous basis at present or within the past 3 months, and those who are planning to take them during the study period.
12) Pregnant, lactating, or of childbearing potential or intention to become pregnant during the study period.
13) Individuals who participated in other clinical studies in the past 3 months.
14) Individuals who are or whose family is engaged in healthy or functional foods.
15) Individuals judged inappropriate for the study by the principal.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
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
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ASAHI SOFT DRINKS CO., LTD.
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062713
