Tokyo, May 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061690) titled 'Clinical Trial on Leucine Requirement in Japanese Elderly Men Using the Indicator Amino Acid Oxidation (IAAO) Method' on May 26.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Dose comparison

Primary Sponsor: Institute - CPCC Company Limited

Condition: Condition - Healthy elderly male Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the requirement of L-leucine in healthy Japanese elderly males. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Oral intake of one of the study foods A to G in each period. Interventions/Control_2 - Oral intake of one of the study foods A to G in each period.

Eligibility: Age-lower limit - 65 years-old

Gender - Male Key inclusion criteria - 1. Japanese men aged 65 to below 75 years at the time of consent acquisition. 2. Individuals who have a habit of consuming three meals per day. 3. Individuals whose body weight at the screening examination is between 50 and 80 kg. 4. Individuals with a body mass index (BMI) of 18.5 kg/m2 or higher and less than 30.0 kg/m2. 5. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents. Key exclusion criteria - 1. Individuals who are aware of a weight change of more than 5 kg in the month prior to obtaining consent. 2. Individuals with excessive alcohol intake. 3. Individuals suffering from diseases that affect protein and amino acid metabolism, such as diabetes, cancer, liver disease, kidney disease, HIV, etc. 4. Individuals with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 5. Individuals with allergies to medications and/or food. 6. Individuals with known infection with hepatitis B or C virus, HIV, or syphilis, or those who test positive for these infections at screening. 7. Individuals who donated blood or component (200 mL) within the last 1 months. 8. Individuals who donated blood (400 mL) within the last 3 months. 9. Individuals who being collected in total of blood (1200 mL) within the last 12 months and in this study. 10. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator. Target Size - 7

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 22 Day Date of IRB - 2026 Year 04 Month 17 Day Anticipated trial start date - 2026 Year 05 Month 27 Day Last follow-up date - 2026 Year 09 Month 02 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069940

Disclaimer: Curated by HT Syndication.