UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058476 |
|---|---|
| Receipt number | R000066639 |
| Scientific Title | The study for exploring functional materials in the frailty. -A randomized, parallel-group comparison study - |
| Date of disclosure of the study information | 2025/07/18 |
| Last modified on | 2026/10/01 15:58:57 |
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Basic information
Public title
The study for exploring functional materials in the frailty.
-A randomized, parallel-group comparison study -
Acronym
The study for exploring functional materials in the frailty.
Scientific Title
The study for exploring functional materials in the frailty.
-A randomized, parallel-group comparison study -
Scientific Title:Acronym
The study for exploring functional materials in the frailty.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of Food Material A or Food Material B continuously intake for 12 weeks on the frail status of men between 60 and 80 years old, who have been classified as pre-frail or frail through urinary metabolite analysis, compared to the non-intake group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary metabolites
Key secondary outcomes
1) Grip strength
2) The 6-Meter Walking Test
3) Turn up Go(Time up and go test)
4) The Eyes opened Single Leg Balance Test
5) SMI
6) The Japan Science and Technology Agency Index of Competence
7) The Zung Self-Rating Depression Scale
8) GAD-7
9) WHO-5
10) Frailty Basic Checklist
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of one bottle of study Food A once a day for 12 weeks.
Interventions/Control_2
Intake of one bottle of study Food B once a day for 12 weeks.
Interventions/Control_3
No intake of study food.
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Men between 60 and 80 years of age at the time of obtaining consent.
2) Those who are aware that their physical strength has decreased compared to the past.
3) Those who are determined to be in the borderline range in the urinary VOC (frailty index) measurement performed in the screening test.
4) Those who scored 13 points or less on the designated evaluation Measures prior to the screening test.
5) Those who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study after a good understanding, and have agreed to participate in the study in writing.
Key exclusion criteria
1) Those with serious illnesses such as cancer, liver damage, kidney damage, heart disease, diabetes, etc.
2) Those who cannot come to the research site by themselves.
3) Those who have difficulty in taking study food.
4) Those who cannot perform the walking test or one leg stand test (those who need a cane, those who have problems in normal walking, etc.).
5) Those who take health foods that may influence the research results.
6) Those who regularly use study food.
7) Those who have a digestive disease or a history of digestive surgery (except appendicitis).
8) Those who have a history or current history of alcohol dependency.
9) Those who have reported food allergies to the study foods.
10) Those who are unable to abstain from alcohol from the day before each test.
11) Those who suffer from mental illness such as depression.
12) Those who have an extremely irregular dietary habit, those who work late-night shifts (including those who work late-night hours), or those who have an irregular rhythm of life.
13) Those who have participated or wish to participate in trials involving the ingestion of other foods or the use of drugs, or the application of cosmetics and drugs, within 3 months before the date of obtaining consent.
14) Those who are judged by the principal investigator to be inappropriate as study subjects for other reasons.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0004
Address
Anela Bldg. 8F, 3-3-3 Higashi Nihonbashi, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2025 | Year | 07 | Month | 18 | 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
45
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
| 2025 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066639
