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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000048119 |
Receipt No. | R000054838 |
Scientific Title | Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/06/22 |
Last modified on | 2022/06/23 |
Basic information | ||
Public title | Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects | |
Acronym | Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects | |
Scientific Title | Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study | |
Scientific Title:Acronym | Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects | |
Region |
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Condition | |||
Condition | Healthy Japanese subjects | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the effects of consumption of the test food on skeletal muscle in healthy Japanese subjects |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Lean mass at 12 weeks after consumption (12w) |
Key secondary outcomes | Cross-sectional area of rectus abdominis muscle, cross-sectional area of abdominal oblique muscle, total cross-sectional area of rectus abdominis muscle and abdominal oblique muscle, grip strength (right hand, left hand, and both hands average), the number of times of standing up from the chair for 30 seconds, the number of times of raising upper body for 30 seconds, waist circumference, hip circumference, body weight, body mass index, body fat percentage, fat mass (right arm, left arm, right leg, left leg, and trunk (torso)), and muscle mass {right arm, left arm, right leg, left leg, and trunk (torso)} at 12w |
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 | Institution is not considered as adjustment factor. |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 3 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Duration: 12 weeks
Test food: Food containing yeast extract Administration: Dissolve one packet with water and drink it right after waking up *If you forget to take the test food, take it as soon as you remember within the day. Daily dose should be taken within the day and not carried over to the next day. *Perform training at your home with the following content three times a week (at least one day between training days) during the test period: (1) Squats 15 times x three sets (2) Upper body raises 15 times x three sets |
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Interventions/Control_2 | Duration: 12 weeks
Test food: Food containing whey extract Administration: Dissolve one packet with water and drink it right after waking up *If you forget to take the test food, take it as soon as you remember within the day. Daily dose should be taken within the day and not carried over to the next day. *Perform training at your home with the following content three times a week (at least one day between training days) during the test period: (1) Squats 15 times x three sets (2) Upper body raises 15 times x three sets |
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Interventions/Control_3 | Duration: 12 weeks
Test food: Placebo food Administration: Dissolve one packet with water and drink it right after waking up *If you forget to take the test food, take it as soon as you remember within the day. Daily dose should be taken within the day and not carried over to the next day. *Perform training at your home with the following content three times a week (at least one day between training days) during the test period: (1) Squats 15 times x three sets (2) Upper body raises 15 times x three sets |
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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 |
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Age-upper limit |
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Gender | Male | |||
Key inclusion criteria | 1. Japanese
2. Men 3. Adults 4. Subjects aged less than 75 5. Healthy subjects 6. Subjects whose BMI are 23 kg/m2 or more and less than 30 kg/m2 7. Subjects whose lean mass are low |
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Key exclusion criteria | 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who have lactose intolerance 5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 6. Subjects currently taking medicines (include herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products (particularly milk) 8. Subjects who are pregnant, breast-feeding, and planning to become pregnant 9. Subjects who suffer from COVID-19 10. Subjects who cannot perform the specified training 11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 12. Subjects who are judged as ineligible to participate in the study by the physician |
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Target sample size | 57 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Medical Corporation Seishinkai, Takara Clinic | ||||||
Division name | Director | ||||||
Zip code | 141-0022 | ||||||
Address | 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan | ||||||
TEL | 03-5793-3623 | ||||||
t-takara@takara-clinic.com |
Public contact | |||||||
Name of contact person |
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Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | 112-0002 | ||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan. | ||||||
TEL | 03-3818-0610 | ||||||
Homepage URL | |||||||
nao@orthomedico.jp |
Sponsor | |
Institute | ORTHOMEDICO Inc. |
Institute | |
Department |
Funding Source | |
Organization | Nakahara Co., Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | the ethical committee of the Takara Clinic, Medical Corporation Seishinkai |
Address | 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan. |
Tel | 03-5793-3623 |
IRB@takara-clinic.com |
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 | 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054838 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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