UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000042240 |
| Receipt No. | 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 (Ver. 1) |
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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 |
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| Condition | |||
| Condition | elderly people with low muscle strength and gait speed | ||
| Classification by specialty |
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| 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 |
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| Interventions/Control_1 | daily intake of test food containing 3 g of placenta extract for 12 weeks | |
| Interventions/Control_2 | ||
| Interventions/Control_3 | ||
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| Interventions/Control_5 | ||
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| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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. |
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| 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. |
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| Target sample size | 30 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| Institute | Japan Bio Products Co., Ltd. |
| Institute | |
| Department | |
| 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 | |
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| Date of disclosure of the study information |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| 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 |
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| Participant flow | Enrolled n=27 Completed n=24 Analyzed n=24(for the primary outcomes) |
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| 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). |
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| Outcome measures | <primary outcome> gait speed grip strength <secondary outcome> calf circumference QOL score total testosterone DHEA-S IGF-1 adverse event laboratory examination |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Date trial data considered complete |
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| Date analysis concluded |
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| Other | |
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| Management information | |||||||
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048146 |
