UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046306 |
|---|---|
| Receipt number | R000052838 |
| Scientific Title | A verification study on frailty prevention effect. -A randomized, controlled study- |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2022/12/07 12:50:27 |
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Basic information
Public title
A verification study on frailty prevention effect.
-A randomized, controlled study-
Acronym
A verification study on frailty prevention effect.
Scientific Title
A verification study on frailty prevention effect.
-A randomized, controlled study-
Scientific Title:Acronym
A verification study on frailty prevention effect.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and evaluate the frailty prevention effect of ingesting two meals a day of research foods that a well-balanced combination of multiple nutritional ingredients that are considered to be good for health, in comparison with the non-intake group of the research food (exercise only group), For elderly people aged 60 and over.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･Grip strength
･Leg strength
･Walking function
･Bone density
･MCI Screen
Time:0w,6w,12w
Key secondary outcomes
･Estimated muscle mass, muscle rate and muscle mass by site (Torso, right arm, left arm, right leg, left leg).
･Frailty Basic Checklist
･Physical Frailty Syndrome Questionnaire Survey.
Time:0w,6w,12w
Exploratory endpoint
･Motor function test
･Body measurements
･Questionnaire survey
･Special stool test
･Blood test
･Special urine test
･Special saliva test
Time:0w,6w,12w
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
(1) Ingest research foods twice a day for 12 weeks.
(2) Participate in exercise class 4 times.
(3) Do resistance exercises 3-5 times a week at home.
Interventions/Control_2
(1) Participate in exercise class 4 times.
(2) Do resistance exercises 3-5 times a week at home.
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) Men and women aged 60 and over at the time of consent acquisition
(2) Subjects who are prefrailty or frailty in J-CHS (2020).
(3) Subjects who were in the range from healthy to MCI in the cognitive function test.
(4) Subjects who can take research foods twice a day.
(5) Subjects who have been vaccinated with the new corona vaccine 2 times or more.
(6) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who has determined to be inappropriate as a Research subject by the principal investigator by a blood test performed on a screening test.
(2) Subjects who donated blood within 4 weeks from the date of consent acquisition, or willing to donate blood during the research period.
(3) Subjects who have chronic disease and have serious complications.
(4) Subjects who has food allergy.
(5) Subjects who are on exercise therapy or diet.
(6) Subjects who cannot perform the prescribed exercise, due to long-term care, motor dysfunction, or dementia, etc.
(7) Subjects who cannot complete research foods twice a day due to having a small appetite, unbalanced diet, or dysphagia, etc.
(8) Subjects who have extremely irregular diet.
(9) Subjects who ate taking protein.
(10) Subjects who have a drinking habit of exceeding 60g per day on average in terms of pure alcohol.
(11) Subjects who smoke 21 or more cigarettes a day.
(12) Subjects who with irregular life rhythms such as shift work and late-night work.
(13) Subjects who take health foods (including Food for Specified Health Uses or Foods with Function Claims) and/or supplements on a daily basis.
(14) Subjects who wearing implantable medical devices such as cardiac pacemakers, and/or have metal implants or bolts inside their bodies, and/or have a defect in any of the limbs.
(15) Subjects who have digestive disorders that affect digestion and absorption and/or have a history of digestive surgery.
(16) Those who do not own a microwave.
(17) Subjects who are participating in other studies that using foods, pharmaceuticals, and cosmetics now, or who have been participated or are willing to participate in other studies within a month from the date of informed consent.
(18) Subjects who are judged as unsuitable for the study by the principal investigator for the other reasons.
Target sample size
110
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
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
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
non-disclosure
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 Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
医療法人財団健康睡眠会 日本橋循環器科クリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 10 | 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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2021 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052838
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
