Unique ID issued by UMIN | UMIN000038963 |
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Receipt number | R000044434 |
Scientific Title | Safety evaluation of excessive intake of peptide: a randomized, double-blind, placebo-controlled trial |
Date of disclosure of the study information | 2019/12/25 |
Last modified on | 2020/06/08 15:55:40 |
Safety evaluation of excessive intake of peptide
Safety evaluation of excessive intake of peptide
Safety evaluation of excessive intake of peptide: a randomized, double-blind, placebo-controlled trial
Safety evaluation of excessive intake of peptide
Japan |
No
Adult |
Others
NO
To investigate the safety of excessive intake of peptide
Safety
Hematologic test
Biochemistry test
Urinalysis
Blood pressure/pulse
Weight/body mass index
Medical interview
Adverse event and side effect
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of peptide for 4 weeks
Intake of placebo for 4 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1. Subjects who are age of 20 years or older.
2. Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
1. Subjects who have a history of serious illness.
2. Subjects who are under treatment with medication for lifestyle-related disease (diabetes, hypertension, dyslipidemia).
3. Subjects who have digestive tract diseases that affect digestion and absorption, and have had a history of gastrointestinal surgery (excluding appendicitis).
4. Subjects who have a medical history of serious allergy to medicine and food.
5. Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study.
6. Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
7. Subjects who are planning to participate in other clinical studies.
8. Subjects who are judged unsuitable for participating in this study by the principal investigator.
30
1st name | Masahiko |
Middle name | |
Last name | Tokushima |
Maebashi North Hospital
Director
371-0054
692 Shimohosoi-machi,Maebashi-shi,Gumma
027-235-3333
sagawa@mc-connect.co.jp
1st name | Eiji |
Middle name | |
Last name | Yoshikawa |
KSO Corporation
Sales department
105-0023
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
MORINAGA MILK INDUSTRY CO.,LTD.
Profit organization
Ethical Committee of Kobuna Orthopedics Clinic
5-656-17 Joutou-machi, Maebashi-shi, Gunma, Japan
027-212-5608
sagawa@mc-connect.co.jp
NO
医療法人 前橋北病院(群馬県)/ Maebashi North Hospital (Gunma)
2019 | Year | 12 | Month | 25 | Day |
Unpublished
30
Completed
2019 | Year | 10 | Month | 04 | Day |
2019 | Year | 11 | Month | 21 | Day |
2020 | Year | 01 | Month | 15 | Day |
2020 | Year | 03 | Month | 14 | Day |
2019 | Year | 12 | Month | 23 | Day |
2020 | Year | 06 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044434
Research Plan | |
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Research case data specifications | |
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Registered date | File name |
Research case data | |
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