UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050794 |
|---|---|
| Receipt number | R000057660 |
| Scientific Title | Examination of fatigue feeling-reducing effects by test-food intakes (a preliminary study) |
| Date of disclosure of the study information | 2024/04/14 |
| Last modified on | 2024/01/24 12:12:38 |
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Basic information
Public title
Examination of fatigue feeling-reducing effects by test-food intakes (a preliminary study)
Acronym
Examination of fatigue feeling-reducing effects by test-food intakes (a preliminary study)
Scientific Title
Examination of fatigue feeling-reducing effects by test-food intakes (a preliminary study)
Scientific Title:Acronym
Examination of fatigue feeling-reducing effects by test-food intakes (a preliminary study)
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating some kind of reduction effect in a fatigue feeling, by ingesting the test beverage to the subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective questionnaires: Visual Analogue Scale (a general/physical/psychological fatigue feeling, The Profile of Mood States Second Edition (Japanese short ver.)
Key secondary outcomes
1. Acceleration of pulse waveform
2. Antioxidant activity tests (Diacron-reactive oxygen metabolites/biological antioxidant potential/malondialdehyde (thiobarbituric acid-reactive substances) in blood, and 8-hydroxy-2'-deoxyguanosine/15-isoprostane in urine)
3. Saliva examination (cortisol and chromogranin)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test beverage (150 g) to the subject, one bottle a day.
Interventions/Control_2
Ingestion of the placebo beverage (150 g) to the subject, one bottle a 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female subjects ranging in age from 20 to 64.
(2) Subjects who feel tired every day, in spite of their rest.
(3) Subjects who can give informed consent to partake in this study after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who take steadily (not less than three times a week) in the health-specific/functional (e.g., gamma-aminobutyric acid, imidazole dipeptide, reduced coenzyme Q10, L-theanine, citric acid)/supplementary/health foods, which might affect the test results.
(2) Subjects who have taken affecting medicines (e.g., Alinamin-A, Chocola-BB), and have any difficulty in refraining from taking them during this study.
(3) Subjects who take excessive alcohol.
(4) Subjects who are now under another clinical test with some kind of medicine/food, or participated in that within four weeks before this study, or are planning to join that after the consent.
(5) Subjects having a physical labor, or getting excessive exercise every day.
(6) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(7) Pregnant, lactating women, and possibly pregnant ones.
(8) Subjects having drug and/or food allergy.
(9) Subjects who donated over 200 mL of their blood and/or blood components within a month to this study.
(10) Males who donated their whole blood (400 mL) within the last three months to this study.
(11) Females who donated their whole blood (400 mL) within the last four months to this study.
(12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study.
(13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study.
(14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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 | 04 | Month | 14 | 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
10
Results
In the test food group, variations in the primary evaluation item "VAS (mental fatigue)" and secondary evaluation items "blood BAP levels" and "salivary test (cortisol)" indicated potential effects of the test food on reducing mental fatigue, enhancing antioxidant capacity, and alleviating stress.
Results date posted
| 2024 | Year | 01 | Month | 24 | Day |
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 | 03 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 18 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057660
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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