Tokyo, Nov. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059693) titled 'A Pilot Study on the Relationship Between Protein Metabolism Indicators and Nutritional Status in Healthy Adult Males: An Open-Label, Single-Arm Trial' on Nov. 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Otsuka Pharmaceutical Co., Ltd.

Condition: Condition - Healthy Adult Males Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To explore the relationship between protein metabolism indicators and blood component concentrations. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Intake of standardized meals

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - 1) Individuals who provided written informed consent to participate in this trial. 2) Healthy adult males aged 20 to 65 years. 3) Individuals who are able to follow the investigator's instructions and adhere to the scheduled intake of the 15N-Glycine and the standardized meals, blood sampling, urine collection, and maintenance of rest. Key exclusion criteria - 1) Individuals judged by the principal investigator to be ineligible for this trial based on the results of the preliminary medical examination. 2) Individuals who showed a high-sensitivity CRP level of >= 0.2 mg/dL or an albumin level of < 3.8 g/dL at the time of the preliminary medical examination. 3) Individuals with diseases of the gastrointestinal, cardiovascular, or endocrine systems, or with a history of such conditions, as well as those who regularly take medications for the treatment of these diseases, who are judged by the principal investigator to be ineligible for this trial. 4) Individuals with food allergies. 5) Individuals who have had 200 mL or more of whole blood collected within the past 4 weeks, or 400 mL or more within the past 12 weeks prior to the first blood sampling. 6) Individuals who are currently participating in another trial or are scheduled to participate in another trial. 7) Individuals who are judged to be ineligible for this trial for other reasons by the principal investigator or the study director. Target Size - 14

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 06 Day Date of IRB - 2025 Year 11 Month 06 Day Anticipated trial start date - 2025 Year 11 Month 07 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068229

Disclaimer: Curated by HT Syndication.