UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042240 |
|---|---|
| Receipt number | R000048146 |
| Scientific Title | A clinical study of the efficacy and safety of placenta extract in elderly people with low muscle strength and gait speed -Open label trial- |
| Date of disclosure of the study information | 2020/10/28 |
| Last modified on | 2020/10/26 16:06:08 |
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Basic information
Public title
A research of placenta extract in elderly people with low muscle strength and gait speed
Acronym
A research of placenta extract in elderly people with low muscle strength and gait speed
Scientific Title
A clinical study of the efficacy and safety of placenta extract in elderly people with low muscle strength and gait speed -Open label trial-
Scientific Title:Acronym
A research of placenta extract in elderly people with low muscle strength and gait speed
Region
| Japan |
Condition
Condition
elderly people with low muscle strength and gait speed
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of placenta extract for the assessment of sarcopenia indices in the elderly with low muscle strength and gait speed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
gait speed
grip strength
Key secondary outcomes
calf circumference
QOL score
total testosterone
DHEA-S
IGF-1
adverse event
laboratory examination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
daily intake of test food containing 3 g of placenta extract for 12 weeks
Interventions/Control_2
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) Male and female over 65 years of age
2) Those whose grip strength is less than 30 kg for men and 20 kg for women.
3) Those whose gait speed is less than 1.2 m/sec.
4) A person who has obtained written consent
5) Patients with complications or pre-existing conditions that are stable and judged by the principal investigator to be eligible to participate in this clinical study.
Key exclusion criteria
1)Persons with allergic symptoms to the test food and excipients
2) Persons with difficulty walking or with diseases that are known to affect their ability to move (known muscular disease, peripheral vascular disease causing intermittent claudication, central and peripheral nerve disease (e.g. Parkinson's disease, spinal cord disease, motor neuron disease, etc.), severe dementia, severe diabetes).
3) Any person with a history or suspicion of being affected by cachexia
4) Anyone taking a BCAA supplement.
5) Those who continue to take placenta extract
6) Those who have participated in another clinical trial within the past six months
7) A person who is judged by the principal investigator to be unsuitable to participate in the clinical trial.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Medical Corporation Sofuku-kai Fukuro Clinic Todoroki
Division name
Head
Zip code
158-0082
Address
Hulic Todoroki Building 3F, 3-5-2 Todoroki, Setagaya-ku, Tokyo
TEL
03-5758-3270
yamaguchi@296296.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Mimura |
Organization
Japan Bio Products Co., Ltd.
Division name
Medical Affairs Department
Zip code
151-0063
Address
1-44-4 Tomigaya, Shibuya-ku, Tokyo
TEL
03-3481-6061
Homepage URL
t_mimura@placenta-jbp.co.jp
Sponsor or person
Institute
Japan Bio Products Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japan Bio Products 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
Fukuro Clinic Todoroki Ethics Committee
Address
Hulic Todoroki Building 3F, 3-5-2 Todoroki, Setagaya-ku, Tokyo
Tel
03-5758-3270
yamaguchi@296296.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
| 2020 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
27
Results
Median gait speed was improved from 0.73 m/s to 0.88 m/s (p<0.001). Median grip strength was unchanged from 14.9 kg before to 15.3 kg after ingestion (p=0.539).
Among secondary outcomes evaluated in the exploratory analyses, quality of life was improved.
Results date posted
| 2020 | Year | 10 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males and females over 65 years of age with low muscle strength and gait speed
Participant flow
Enrolled n=27
Completed n=24
Analyzed n=24(for the primary outcomes)
Adverse events
Two participants dropped out from the study due to fall and fracture or constipation, but we judged no causal relationships between the intake of test food and the events. There were no safety findings of note in other test results (e.g., laboratory tests).
Outcome measures
<primary outcome>
gait speed
grip strength
<secondary outcome>
calf circumference
QOL score
total testosterone
DHEA-S
IGF-1
adverse event
laboratory examination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 27 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 26 | Day |
Last modified on
| 2020 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048146
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