Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058221) titled 'Elucidation of Energy Metabolism Mechanisms in Parkinson Disease Using Doubly Labeled Water' on Aug. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - Parkinson disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To measure energy expenditure in Parkinson disease Basic objectives2 - Others

Intervention: Interventions/Control_1 - On the first day of the study, participants will ingest doubly labeled water containing stable isotopes of oxygen and hydrogen. The volume administered will be approximately 1.5 g per kilogram of body weight, depending on the each body size.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Eligible participants will be male or female patients diagnosed with Parkinson disease HY up to IV, aged 20 years or older and under 80 years, who have provided written informed consent to participate in this study. Prior to obtaining consent, participants will be provided with a detailed explanation of the study using an information sheet, including a description of the procedures, devices, and facilities involved, to ensure full understanding.

Inclusion criteria: Patients diagnosed with Parkinson disease who visit the Department of Neurology at Takagi Hospital or Fukuoka Sanno Hospital between April 1, 2025, and March 31, 2026. Patients capable of providing written informed consent of their own free will. Patients aged 20 years or older and under 80 years at the time of consent. Disease severity classified as H&Y stage up to IV. No restriction based on sex. No restriction based on inpatient or outpatient status. Key exclusion criteria - Participants will be excluded from the study if they meet any of the following conditions

Individuals unable to comply with the study protocol, including proper sample storage and scheduled outpatient visits. Individuals with comorbid gastrointestinal disorders that cause malabsorption. Individuals with comorbid endocrine disorders that affect energy intake. Individuals with comorbid psychiatric disorders that result in pathological appetite loss. Individuals with comorbid neoplastic diseases. Individuals with severe renal impairment. Individuals with cognitive impairment. Individuals in a state of starvation. Individuals with a BMI of 30 or higher. Individuals using implanted medical devices such as deep brain stimulators. Individuals with extremely irregular dietary habits. Individuals currently participating in, or intending to participate in, other clinical trials involving the consumption of food or medications, or the application of cosmetics or pharmaceuticals. Individuals with habitual alcohol consumption or smoking that cannot be controlled during the study period. Any individual who, despite obtaining the attending physicians consent, is deemed by the principal investigator to be unsuitable for safe participation in this study. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 01 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2026 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066564

Disclaimer: Curated by HT Syndication.