UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057816 |
|---|---|
| Receipt number | R000066074 |
| Scientific Title | Effects of Intake of Supplements Containing Plant Extracts on Physical Function in Healthy Older Adults: An Exploratory Clinical Trial |
| Date of disclosure of the study information | 2025/05/11 |
| Last modified on | 2025/05/09 16:16:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Intake of Supplements Containing Plant Extracts on Physical Function in Healthy Older Adults: An Exploratory Clinical Trial
Acronym
Effects of Intake of Supplements Containing Plant Extracts on Physical Function in Healthy Older Adults: An Exploratory Clinical Trial
Scientific Title
Effects of Intake of Supplements Containing Plant Extracts on Physical Function in Healthy Older Adults: An Exploratory Clinical Trial
Scientific Title:Acronym
Effects of Intake of Supplements Containing Plant Extracts on Physical Function in Healthy Older Adults: An Exploratory Clinical Trial
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to explore the effectiveness of supplements containing plant extracts on physical function in healthy older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Between-group comparisons of changes from baseline to 12 weeks in the SF-36 Physical Component Summary, the 30-Second Chair Stand Test (30s-CST), and the 2-Minute Step-in-Place Test
Key secondary outcomes
1) SF36v2
2) Fatigue Visual Analog Scale
3) Muscle Strength
4) Usual Gait Speed
5) Skeletal Muscle Ultrasound Examination
6) Inflammatory Markers
7) Skeletal Muscle Atrophy Markers
8) Myofibrillar Protein Indicators
9) Oxidative Stress
10) Oxidative Stress Related Genes
11) Physical Activity
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 | Behavior,custom |
Interventions/Control_1
1) Subjects receive plant extract-containing supplements daily for 12 weeks.
2) Subjects receive a nutrition program four times during the intervention period.
Interventions/Control_2
1).Subjects receive of placebo for 12 weeks.
2) Subjects receive a nutrition program four times during the intervention period.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Participants who have the capacity to provide informed consent, have received a thorough explanation of the purpose and details of the study, fully understand the information provided, and voluntarily agree in writing to participate in the study.
2) Participants who are men or women aged 65 years or older at the time of obtaining consent.
Key exclusion criteria
1) Participants with a history of heart failure, myocardial infarction, or neurodegenerative diseases
2) Participants currently receiving treatment for atrial fibrillation, arrhythmia, liver dysfunction, renal dysfunction, cerebrovascular disease, rheumatoid arthritis, or diabetes
3) Participants diagnosed with dementia or those who scored 23 or lower on the Mini-Mental State Examination (MMSE) during a recent comprehensive health check-up
4) Participants with known or suspected allergies to broccoli, other foods, or medications
5) Participants who consume supplements, foods, quasi-drugs, or pharmaceuticals that may affect physical function or fatigue more than three times per week
6) Participants who consume broccoli sprouts or kale more than three times per week
7) Participants who consume supplements or green juice derived from broccoli, broccoli sprouts, kale, or wasabi more than three times per week
8) Participants who are currently enrolled in another clinical trial, have participated in another clinical trial within the past three months, or are expected to participate in another trial during the study period
9) Participants who are deemed unable to communicate effectively in Japanese
10) Participants who are deemed ineligible by the principal investigator or study physician due to illness or other reasons
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Shida |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
t_shida@tmig.or.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Shida |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
t_shida@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Kagome Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology Institutional Review Board
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-3241
rinsyoushiken@tmghig.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
東京都健康長寿医療センター研究所（東京都）/Tokyo Metropolitan Institute for Geriatrics and Gerontology (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 11 | 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
53
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
| 2025 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066074
