UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047170 |
|---|---|
| Receipt number | R000053807 |
| Scientific Title | A study of the effects of research food intake on fatigue in women |
| Date of disclosure of the study information | 2023/08/03 |
| Last modified on | 2023/01/17 13:47:22 |
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Basic information
Public title
A study of the effects of research food intake on fatigue in women
Acronym
A study of the effects of research food intake on fatigue in women
Scientific Title
A study of the effects of research food intake on fatigue in women
Scientific Title:Acronym
A study of the effects of research food intake on fatigue in women
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of reducing fatigue and safety of plant-derived product during continuous intake for 12 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 adult shortening version
Evaluate before ingestion, 4 weeks, 8 weeks, and 12 weeks after ingestion.
Key secondary outcomes
OSA Wake-up Sleep Sense Questionnaire (MA Version), Fatigue VAS, Simplified Menopause Index (SMI)
Evaluate before ingestion, 4 weeks, 8 weeks, and 12 weeks after ingestion.
Saliva test (s-IgA concentration in saliva, s-IgA secretion in saliva per unit time)
Evaluate before ingestion and 12 weeks after ingestion.
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
Take research food 3 tablets daily for 12 weeks
Interventions/Control_2
Take placebo 3 tablets daily 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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy women between 45 and 65 years of age who are feeling tired.
(2) "Fatigue - Inertia" score of 50 or more and "Vigor - Activity" score of 50 or less on the POMS2 for Adults (short version) at the time of the pretest.
Key exclusion criteria
(1) Those who regularly use food fortified with plant-derived product.
(2) Those who regularly use medicines, foods for specified health use, and health foods for the purpose of improving sleep, stress, and fatigue (including outpatient treatment and treatment).
(3) Those who wake up in the middle of the night due to frequent urination.
(4) Those who are undergoing treatment for sleep apnea syndrome, have a history of the diagnosis, or are strongly suspected of having the condition.
(5) Those who work day and night shifts, those whose working hours are irregular, those who are engaged in physical labor such as heavy lifting, those whose working days (days off) are irregular, and those who will work multiple night shifts during this research period.
(6) Those who have been diagnosed with chronic fatigue syndrome.
(7) Those who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have problems participating in the research.
(8) Those who are judged to be unsuitable as subjects based on their responses to the lifestyle questionnaire.
(9) Persons at risk of developing allergies related to the research.
(10) Those with diseases requiring constant medication (both external and internal), those with diseases under treatment (except for dry eye and dental caries treatment), and those with a history of serious diseases requiring medication (diabetes, liver disease, kidney disease, heart disease, etc.)
(11) Persons whose physical measurements, physical test values, and clinical test values before the start of ingestion show significant deviations from the standard range.
(12) Those who are participating in other clinical research at the start of this study.
(13) Those who plan to become pregnant or breastfeed during the research period.
(14) Any other person who is judged as inappropriate as a subject by the Chief Medical Officer.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Tanaka |
Organization
TOWA CORPORATION
Division name
Research and Sales Division
Zip code
161-0034
Address
2-11-1 Kamiochiai, Shinjuku-ku, Tokyo
TEL
03-3362-6070
e.tanaka@towacorp.co.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Fukuchi |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section
Zip code
162-0821
Address
1-8 Tsukudocho, Shinjuku-ku, Tokyo Kagurazaka AK Building 7F
TEL
070-3023-8203
Homepage URL
fukuchi.saki473@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOWA CORPORATION
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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
| 2023 | Year | 08 | Month | 03 | 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
| 2022 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 03 | 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 | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053807
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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