Parkinson'
Conditions
Interventions
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).
Sponsors
International University of Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
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 <80 years Disease severity: Hoehn and Yahr stage I to IV Sex:no restriction Inpatient or outpatient status: no restriction
Exclusion criteria
Exclusion criteria: Inability to comply with the study procedures, including proper handling and storage of biological samples and adherence to scheduled outpatient visits Presence of gastrointestinal disorders associated with impaired nutrient absorption Presence of comorbid endocrine disorders affecting energy intake Presence of psychiatric disorders associated with pathological loss of appetite Presence of malignant or neoplastic diseases Severe renal dysfunction: creatinine clearance <30 mL/min Cognitive impairment: Mini Mental State Examination score <22 Starvation or severe undernutrition Body mass index =>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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total daily energy expenditure determined by measurement of 18O and 2H elimination rates using the doubly labeled water method | — |
Countries
Japan
Contacts
Public ContactShinsuke Fujioka
International University of Health and Welfare Department of Neurology
Outcome results
None listed