UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061791 |
|---|---|
| Receipt number | R000070538 |
| Scientific Title | Effects of diosgenin intake and Karate exercises on physical fitness in healthy older adults - Placebo-controlled, randomized, parallel-group comparative study- |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/03 18:55:35 |
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Basic information
Public title
Effects of diosgenin intake and Karate exercises on physical fitness in healthy older adults
- Placebo-controlled, randomized, parallel-group comparative study-
Acronym
Effects of diosgenin intake and Karate exercises on physical fitness in healthy older adults
- Placebo-controlled, randomized, parallel-group comparative study-
Scientific Title
Effects of diosgenin intake and Karate exercises on physical fitness in healthy older adults
- Placebo-controlled, randomized, parallel-group comparative study-
Scientific Title:Acronym
Effects of diosgenin intake and Karate exercises on physical fitness in healthy older adults
- Placebo-controlled, randomized, parallel-group comparative study-
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous diosgenin intake and regular Karate exercises on physical fitness improvement in healthy older male and female.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait function(gait speed, cadence, stride length, gait speed during cognitive tasks, and gait variability)
Key secondary outcomes
Visual Analog Scale (VAS) for pain during walking, lower limb muscle strength (Stand-up Test), handgrip strength, bone metabolism markers (TRACP-5b, BAP, P1NP), DHEAs, estrogen, bone mineral density, skeletal muscle mass, balance tests: postural control (static balance) and postural stability during visual occlusion, and serum Rubicon protein levels (autophagy inhibitor), Safety assessment (blood tests, body weight, BMI, blood pressure, and adverse events).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Test food intake with Karate exercises
Interventions/Control_2
Test food intake without Karate exercises
Interventions/Control_3
Control food intake with Karate exercises
Interventions/Control_4
Control food intake without Karate exercises
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Male and female individuals aged 65 to 79 years.
2) Healthy individuals capable of maintaining a one-legged stance with eyes open for 10 seconds or longer.
3) Individuals with a Body Mass Index (BMI) of 18.5 to less than 30.0 kg/m2.
4) Individuals who have received a full explanation of the study's purpose and procedures and have provided written informed consent prior to participation.
Key exclusion criteria
1) Individuals meeting the diagnostic criteria for sarcopenia (handgrip strength less than 26 kg for male or less than 18 kg for female, and a gait speed less than 0.8 m/sec)
2) Individuals with knee osteoarthritis or rheumatoid arthritis.
3) Individuals with a regular exercise habit of twice or more per week.
4) Individuals who have practiced Karate within the past 3 months.
5) Individuals who have received medical treatment for joint pain (such as in the knees or lower back) within 3 months prior to the start of the study.
6) Individuals who have sustained severe musculoskeletal injuries (e.g., fractures, tendon ruptures, or muscle strains) within the past year, or who find it difficult to perform physical exercise due to musculoskeletal pain or discomfort.
7) Individuals with a history of gastrointestinal surgery (excluding appendectomy).
8) Individuals with a current or past medical history of serious diseases (e.g., malignant tumors, cardiac disease, or neurological disorders).
9) Individuals who routinely consume health foods (e.g., Food for Specified Health Uses [FOSHU], dietary supplements, Foods with Function Claims) or calcium/vitamin D supplements that may affect the study parameters.
10) Individuals who are unable to discontinue the consumption of health foods (e.g., FOSHU, dietary supplements) from the time of informed consent until the completion of the study.
11) Heavy drinkers with an average pure alcohol intake of 60g per day or more
12) Individuals with extremely irregular dietary habits.
13) Shift workers or night-shift workers.
14) Individuals with a history of anaphylactic shock.
15) Individuals with an allergy to Japanese yam (Yamaimo).
16) Individuals who have participated in other clinical trials within 3 months prior to the date of informed consent, or who plan to participate in other clinical trials during the study period.
17) Individuals judged to be inappropriate for participation by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kuriyama |
Organization
Anti-Aging Pro Corporation
Division name
Research and Development Division
Zip code
160-0023
Address
5F Kotobuki Bldg., 7-9-6 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-6300-0816
kuri@a2-pro.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Otake |
Organization
feileB Co., Ltd
Division name
Clinical Research Support dev.
Zip code
170-0013
Address
1-18-1 Higashiikebukuro Toshima-ku Tokyo Japan
TEL
03-4332-1770
Homepage URL
otake@feileb.jp
Sponsor or person
Institute
feileB Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Anti-Aging Pro 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
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku, Tokyo
Tel
06-6882-1130
ethics_board@drc-web.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
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The food intervention is double-blinded.
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070538
