UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055115 |
|---|---|
| Receipt number | R000062960 |
| Scientific Title | Effects of exercise and green tea consumption interventions on physical and mental function in older people |
| Date of disclosure of the study information | 2024/08/07 |
| Last modified on | 2025/07/31 12:15:44 |
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Basic information
Public title
Effects of exercise and green tea consumption interventions on physical and mental function in older people
Acronym
Testing the effectiveness of exercise and green tea interventions in older people
Scientific Title
Effects of exercise and green tea consumption interventions on physical and mental function in older people
Scientific Title:Acronym
Testing the effectiveness of exercise and green tea interventions in older people
Region
| Japan |
Condition
Condition
Older people
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the effects of exercise and green tea interventions on improving physical and mental function in healthy older people with age-related decline in walking function and muscle strength.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical function (grip strength, lower limb muscle strength, gait speed, physical performance tests, balance assessment), body composition
Key secondary outcomes
1) Cognitive function
2) Frailty
3) Depression
4) Lifestyle (sleep and physical activity)
5) Urinary biomarkers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Intervention group:
Duration 24 weeks
Green tea powder consumption
Salon (once/week)
Exercise classes (once a month)
Interventions/Control_2
Control group:
Duration 24 weeks
Placebo powder consumption
Salon (once/week)
Exercise classes (once/month)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Feel a decrease in walking speed compared to before
2) Feel a decrease in muscle strength in everyday activities
3) People who fall under either 1) or 2) or both
4) Men and women aged 60 and over
Key exclusion criteria
1) Those who do not intend to exercise during the period.
2) Those who drink green tea frequently (more than 4 cups per day)
3) Currently taking medication or receiving outpatient treatment for a serious medical condition
4) Those currently under medical supervision for exercise or diet therapy
5) Individuals for whom exercise is contraindicated by a physician's judgment
6) People who have ever felt unwell after the consumption of green tea
7) Individuals with a current or past history of drug or alcohol addiction
8) Individuals who are currently receiving outpatient treatment for mental disorders (e.g. depression) or sleep disorders, or who have a history of mental illness
9) Individuals with extremely irregular lifestyles and rhythms, such as eating and sleeping patterns
10) Pacemaker users
11) Individuals who have participated in other clinical trials (research) within 3 months prior to the date of consent, or who plan to participate in other clinical trials (research) during the study period
12) Persons who are unable to comply with the recording of compliance with the various survey forms
13) People with allergies to green tea, barley grass or starch
14) Individuals who are otherwise deemed ineligible
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hyuma |
| Middle name | |
| Last name | Makizako |
Organization
Kagoshima University
Division name
Department of Physical Therapy, School of Health Sciences, Faculty of Medicine
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima, 890-8544
TEL
099-275-5111
makizako@health.nop.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daijo |
| Middle name | |
| Last name | Shiratsuchi |
Organization
Kagoshima University
Division name
Department of Physical Therapy, School of Health Sciences, Faculty of Medicine
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima, 890-8544
TEL
099-275-5111
Homepage URL
shiratsuchi@health.nop.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Hyuma Makizako
Funding Source
Organization
ITO EN Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Central Research Institute, ITO EN Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee on Clinical Research, Sakuragaoka Campus, Kagoshima University
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.ac.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
鹿児島大学（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 07 | 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
78
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062960
