UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057482 |
|---|---|
| Receipt number | R000065671 |
| Scientific Title | An exploratory clinical study investigating the beneficial effects of plant extract intake on aging-related symptoms and quality of life.: Randomized double-blind placebo-controlled parallel group comparison study |
| Date of disclosure of the study information | 2025/04/06 |
| Last modified on | 2025/04/01 14:48:23 |
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Basic information
Public title
An exploratory clinical study investigating the beneficial effects of plant extract intake on aging-related symptoms and quality of life.
Acronym
An exploratory clinical study investigating the beneficial effects of plant extract intake on aging-related symptoms and quality of life.
Scientific Title
An exploratory clinical study investigating the beneficial effects of plant extract intake on aging-related symptoms and quality of life.: Randomized double-blind placebo-controlled parallel group comparison study
Scientific Title:Acronym
An exploratory clinical study investigating the beneficial effects of plant extract intake on aging-related symptoms and quality of life.: Randomized double-blind placebo-controlled parallel group comparison study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of plant extracts on aging-related symptoms and QOL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective cognitive decline-questionnaire(My-Cog)
25-question geriatric locomotive function scale
Hearing Handicap Inventory for Adults
.
Key secondary outcomes
Subjective cognitive decline-questionnair(Their-Cog)
Everyday memory checklist
Mini-Mental State Examination - Japanese version
Brain Health Check R
Grip Strength
Body composition(Muscle Mass, Appendicular Skeletal Muscle Index, Phase Angle)
Hearing Disability and Handicap Scale
Tinnitus Handicap Inventory
Oral Fraily Index-8
Oral Health Impact Profile-49
National Eye Institute Visual Function Questionnaire-25
Center for Epidemiologic STudies Deoression Scale
Skindex-29
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
Intake of test food for 16 weeks
Interventions/Control_2
Intake of placebo food for 16 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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Japanese men and women aged between 40 and 69.
(2) Subjects who feel a decline in cognitive function, motor function, or auditory function (falling under any of the categories below).
1. A total score of 7 or more on the SCD-Q (My-Cog)
2. A total score of 7 or more on the Locomo 25
3. A score of 18 or higher on the HHIA
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1) SUbjects with a history of mental illness, diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disesase, peripheral vascular disease, or other serious disease
(2) Subjects who have had surgery on the digestive tract (excluding appendectomy)
(3) Subjects with a current medical condition or a history of a serious medical condition that required medical treatment
(4) Subjects with autoimmune diseases (Graves' disease, rheumatoid arthritis, Hashimoto's thyroiditis, type 1 diabetes, systemic lupus erythematosus, polymyositis, Sjogren's syndrome, systemic sclerosis, etc.) or a history of such diseases
(5) Subjects with mental illness (depression, etc.), chronic fatigue syndrome, or insomnia, or subjects with a history of such disorders
(6) Subjects undergoing treatment (including counseling) for sleep, stress, or fatigue
(7) Subjects who are unable to walk independently.
(8) Subjects with anemia symptoms
(9) Subjects who regularly use medicines, foods for specified health uses, health foods, etc. that may affect the study
(10) Subjects who are at risk of developing allergies related to the study
(11) Subjects who wish to become pregnant during the study period, pregnant women (including those who may be pregnant), or breastfeeding subjects
(12) Subjects with a MMSE-J score of 23 or less in the screening test
(13) Subjects who participate in strenuous sports and subjects who are trying to lose weight
(14) Subjects who drink more than 40 g of average daily pure alcohol
(15) Subjects who smoke an average of 21 or more cigarettes per day
(16) to (18) are listed in the "Other related information" column
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
5300044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
"Key exclusion sriteria"
(16) Subjects who plan to travel or go on an overseas business trip during the study period, or who plan to go on a domestic business trip or travel for a continuous period of one week or more
(17) Subjects who are participating in other clinical trials at the start of this study
(18) Subjects who are otherwise deemed inappropriate for research by the principal investigator or co-investigator
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065671
