UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051493 |
|---|---|
| Receipt number | R000058719 |
| Scientific Title | Investigation of the efficacy of the test food in improving quality of life (QOL) in Japanese adults. |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2024/04/16 10:37:02 |
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Basic information
Public title
Investigation of the efficacy of the test food in improving quality of life (QOL) in Japanese adults.
Acronym
Investigation of the efficacy of the test food in improving quality of life (QOL) in Japanese adults.
Scientific Title
Investigation of the efficacy of the test food in improving quality of life (QOL) in Japanese adults.
Scientific Title:Acronym
Investigation of the efficacy of the test food in improving quality of life (QOL) in Japanese adults.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the improvement in QOL by ingestion of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS 2-A short T score
Key secondary outcomes
(Secondary outcomes)
SF-36v2, Apathy Scale, Anti-Aging QOL Common Questionnaire, SCD-Q
(Safety evaluation)
Vital signs, physical measurements(body weight and BMI), biochemical test, hematology test, urinalysis, adverse events
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
Continuous intake of the food containing plant extract for 12 weeks.
Interventions/Control_2
Continuous intake of the food not containing plant extract 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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese males and females who are aged 40 years or older and younger than 60 years at the time of written informed consent.
2.Subjects with a T-score for the vigor-activity (VA) scale of 50 or lower and a T-score for the fatigue-inertia (FI) scale of 50 or higher on the POMS 2-A short.
3.Subjects who are fully informed of the purpose and details of the study, capable of giving informed consent, and volunteering to participate in the study based on a full understanding of it, and who have given written informed consent to participate in the study.
Key exclusion criteria
1.Subjects with a history of gastrointestinal resection.
2.Subjects who are being treated for serious illness or who have required medication for serious illness.
3.Subjects with current or previous history of an autoimmune disease.
4.Subjects with current or previous history of a psychiatric disorder, chronic fatigue syndrome, or insomnia.
5.Subjects with previously diagnosed or suspected sleep apnea syndrome.
6.Subjects currently under treatment related to sleep, stress, or fatigue.
7.Subjects engaged in irregular hours of work, work in day and night shifts, or manual labor such as carrying heavy materials.
8.Subjects who are regularly using pharmaceutical products, products designated as "food for specified health uses" or other categories of "health food," or other products that may affect the study.
9.Subjects who may develop allergies related to the study.
10.Subjects who eating, sleeping, and other habits are extremely irregular.
11.Heavy users of alcohol or excessive smokers.
12.Subjects who plan to travel abroad, including business trips, or who plan to travel or business trips in the country for seven or more consecutive days during the study.
13.Subjects who participated in other clinical study within 3 months before the date of informed consent or who plan to participate in other clinical study during the study period.
14.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent.
15.Subjects who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
16.Subjects who have difficulty complying with recording of each survey form.
17.Subjects whose laboratory test values or various test results at screening indicate their ineligibility to participate in the study.
18.Other Subjects who are considered ineligible for participation in the study by the investigator.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
FANCL 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
NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address
Maruito Nishi-Umeda Building 3F, 3-3-45 Umeda Kita-ku, Osaka-shi, Osaka 530-0001 Japan
Tel
06-4797-5660
kanri@ml.amc-clinic.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 | 06 | Month | 30 | 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
84
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 | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 27 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058719
