Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063377) titled 'A pilot study on the efficacy of specific amino acid intake on hepatic fat' on Oct. 22.

Study Type: Interventional

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

Primary Sponsor: Institute - EP-DataWeave Co., Ltd.

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effect of 24-week continuous intake of specific amino acids on hepatic fat Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - One packet of the test food dissolved in approximately 100 mL of water is consumed once daily before bedtime for 24 weeks.

Eligibility: Age-lower limit - 40 years-old = Gender - Male Key inclusion criteria - (1) Men living in or near the Kanto region and aged 40 to 60 years at the preliminary examination. (2) Subjects who have been suspected of fatty liver disease in a health examination or imaging examination such as abdominal ultrasonography within the past year. (3) Subjects who have not been pointed out to have metabolic dysfunction within the past year. (4) Subjects who have not been diagnosed with alcoholic liver disease, viral hepatitis, or autoimmune hepatitis within the past year. (5) Subjects who do not have claustrophobia and are capable of remaining still and holding breath as instructed inside narrow MRI equipment. (6) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study. Key exclusion criteria - (1) Subjects with inborn errors of metabolism. (2) Subjects under follow-up observation or treatment for malignant neoplasms. (3) Subjects with serious heart disease. (4) Subjects with serious renal impairment. (5) Subjects with dietary restrictions due to heart disease, liver disease, digestive disease, kidney disease, diabetes, or other illnesses. (6) Subjects with metallic implants. (7) Subjects with permanent makeup or tattoos judged to carry risks such as burns during MRI examination. (8) Subjects who experienced a significant body weight change within 3 months prior to informed consent. (9) Subjects who regularly consume pharmaceuticals, Foods for Specified Health Uses, Foods with Function Claims, or dietary supplements that may affect liver function or lipid metabolism. (10) Subjects with irregular lifestyles, such as shift workers or night-shift workers. (11) Subjects who participated in other clinical research, clinical trials, or human studies within 1 month prior to the start of this study. (12) Subjects who consume excessive alcohol on a regular basis. (13) Subjects judged to be unsuitable as subjects based on responses to the lifestyle questionnaire. (14) Subjects otherwise judged by the principal investigator to be unsuitable for participation in the study. Target Size - 25

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 22 Day Date of IRB - 2026 Year 10 Month 22 Day Anticipated trial start date - 2026 Year 10 Month 23 Day Last follow-up date - 2027 Year 04 Month 11 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072548

Disclaimer: Curated by HT Syndication.