An Exploratory Study of NST001 for the Prevention of Immobilizing Muscle Atrophy

JRCT ID: jRCT2051230197

Registered date:11/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteochondritis dissecans or articular cartilage injury of the knee
• Date of first enrollment: 13/05/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): NST001 should be taken orally at 1,200 mg twice a day (before breakfast and dinner) for 6 weeks with an appropriate amount of water (about 100~200 mL).

Outcome(s)

• Primary Outcome: The ratio of the change in cross-sectional area of triceps between pre-surgery and 4 weeks after surgery

Secondary Outcome

1) The ratio of the change in cross-sectional area of triceps among pre-surgery, 1week and 4 weeks after surgery
2) The cross-sectional area of triceps 1 week after surgery
3) The cross-sectional area of triceps 4 weeks after surgery
4) The ratio of the change in fat percentage of triceps among pre-surgery, 1week and 4 weeks after surgery
5) The fat percentage of triceps 1 week after surgery
6) The fat percentage of triceps 4 weeks after surgery

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Individuals who are 18 years of age or older at the time of obtaining consent
2. Individuals who are going to receive osteochondral autograft transfer or autologous chondrocyte implantation for osteochondritis dissecans or articular cartilage injury of the knee
3. Individuals who require postoperative immobilization of the knee using knee brace for a week
4. Individuals who can be hospitalized for a month
5. Individuals who have obtained written consent to participate in the study

Exclude criteria

1. Individuals with severe hepatic impairment (AST or ALT more than 4 times the upper limit of the reference value)
2. Individuals with severe renal impairment (eGFR less than 30 mL/min/1.73 m2)
3. Cancer-bearing individuals
4. Individuals who are taking steroids orally or intravenously at the time of obtaining consent
5. Individuals who have taken metformin, alfa glucosidase inhibitors, H2 blockers, proton pump inhibitors (PPIs), oral antimicrobials, intestinal preparations (bifidobacterium preparations, lactic acid bacteria preparations or butyric acid bacteria preparations), and HYA within 2 months prior to obtaining consent.
6. Individuals with inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.) or individuals with a history of gastrointestinal (stomach, duodenum, small intestine, large intestine, etc.) resection
7. Individuals with MRI contraindications (e.g., individuals with non-MRI medical devices, claustrophobic individuals)*
*: For details, refer to the hospital regulations of the clinical trial site.
8. Pregnant women and individuals who may be pregnant, or who are breastfeeding
9. Individuals who have participated in other clinical trials, interventional or invasive clinical studies within 3 months prior to obtaining consent
10. Other individuals who are judged to be inappropriate by the investigator or co-investigator of this study

Related Information

• Primary Sponsor: Ogawa Wataru
• Source(s) of Monetary Support: Noster Inc.