Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060644) titled 'Elucidation of energy metabolism mechanisms in Parkinson's disease using the doubly labeled water method' on March 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's disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In addition to measuring total energy expenditure using the doubly labeled water method, energy intake, energy loss through urine and feces, and physical activity related energy expenditure will be assessed. Through these comprehensive measurements, the relationship between body weight and energy balance in Parkinson's disease will be elucidated. Furthermore, comprehensive profiling of urinary and fecal metabolites, along with electrolyte analyses, will be performed to clarify metabolite and electrolyte balance in patients with Parkinson's disease. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - To measure energy expenditure, participants ingested doubly labeled water containing stable isotopes of oxygen (18O; 10 atom%, Taiyo Nippon Sanso) and hydrogen (2H; 99 atom%, Taiyo Nippon Sanso). The administered dose varied according to body size and was approximately 60 - 90 mL (corresponding to 1.5 g/kg body weight).

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Eligible participants will be male and female patients with Parkinson's disease aged 20 years or older and younger than 80 years, classified as Hoehn and Yahr stage I to IV, who have provided written informed consent to participate in this study. Prior to obtaining consent, the study objectives and procedures will be explained in detail using an information sheet, and participants will be given an overview of the equipment and facilities used in the study to ensure adequate understanding. Written informed consent will be obtained after confirming full comprehension of the study. Patients diagnosed with Parkinson's disease who visit the Departments of Neurology at Takagi Hospital or Fukuoka Sanno Hospital between April 1, 2025, and March 31, 2026

Ability to provide written informed consent voluntarily Age at the time of consent: =>20 years and 30 Use of implantable medical devices, such as deep brain stimulation systems Extremely irregular dietary habits Current participation in, or intention to participate in, other interventional studies involving food intake, medication administration, or the application of cosmetics or pharmaceutical products Habitual alcohol consumption or smoking that cannot be controlled during the study period: participants will be required to abstain during the experimental period Patients with underlying medical conditions who are deemed unsuitable for safe participation in the study by the principal investigator, even if approval is obtained from the attending physician Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 20 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2026 Year 09 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069357

Disclaimer: Curated by HT Syndication.