UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060644 |
|---|---|
| Receipt number | R000069357 |
| Scientific Title | Mechanistic Analysis of Whole-Body Energy Expenditure in Parkinson's Disease Using Doubly Labeled Water |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/10 13:42:26 |
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Basic information
Public title
Elucidation of energy metabolism mechanisms in Parkinson's disease using the doubly labeled water method
Acronym
Elucidation of energy metabolism mechanisms in Parkinson's disease
Scientific Title
Mechanistic Analysis of Whole-Body Energy Expenditure in Parkinson's Disease Using Doubly Labeled Water
Scientific Title:Acronym
Mechanistic Analysis of Whole-Body Energy Expenditure in Parkinson's Disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total daily energy expenditure determined by measurement of 18O and 2H elimination rates using the doubly labeled water method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
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).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | 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 <80 years
Disease severity: Hoehn and Yahr stage I to IV
Sex:no restriction
Inpatient or outpatient status: no restriction
Key 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
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Fujioka |
Organization
International University of Health and Welfare
Division name
Department of Neurology
Zip code
831-0016
Address
141-11, Sakemi, Okawa, Fukuoka, Japan
TEL
0944-87-0001
s.fujioka@ihwg.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Fujioka |
Organization
International University of Health and Welfare
Division name
Department of Neurology
Zip code
831-0016
Address
141-11, Sakemi, Okawa, Fukuoka, Japan
TEL
0944-87-0001
Homepage URL
s.fujioka@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Shinsuke Fujioka
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare, Kyushu Area Institutional Review Board
Address
182-2 Enokizu, Okawa-shi, Fukuoka 831-8501, Japan
Tel
0944-90-2031
q-rinri@ihwg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069357
