UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052921 |
|---|---|
| Receipt number | R000060385 |
| Scientific Title | Investigation of the safety of fasting therapy and analysis of biological aging indices in healthy adults: a pre- and post-comparative study |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2023/11/27 20:39:45 |
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Basic information
Public title
Study to observe the safety of fasting and improvement in aging indices in healthy adults
Acronym
Observational study of safety and improvement of aging indices with fasting
Scientific Title
Investigation of the safety of fasting therapy and analysis of biological aging indices in healthy adults: a pre- and post-comparative study
Scientific Title:Acronym
Fasting Therapy Safety and Biological Aging indices Analysis Study
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Subjects who wish to participate in the fasting program will be instructed to fast (36 to 48 hours of fasting), and blood samples will be taken before and after fasting to analyze changes in biological aging indices and blood sample data.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood samples and body composition will be collected and examined up to 3 times/year before fasting, immediately after fasting, and 1-4 weeks after fasting.
X chromosome copy number Y chromosome copy number Mitochondria number Leukocyte telomere length, epigenetic clock based on epigenetics information, gene expression in blood cells (RT-qPCR, RNA-Seq, non-coding RNA, single cell RNA-Seq), expression of aging-related proteins expression levels (Rubicon, etc.), mosaic chromosomal alteration (mCA) and genotypes using SNP arrays
Key secondary outcomes
Basic patient information: age, gender, medical history, height, weight
Vital information: body temperature, blood pressure, heart rate, heart rate variability, respiratory rate, oxygen saturation
Disease information: name of disease
Laboratory results: urinalysis, blood count, coagulation/fibrinolysis, serum, blood glucose, biochemistry, free testosterone, thyroid hormone, (for cancer patients) tumor markers, QOL
Treatment: information on surgical treatment, chemotherapy, endocrine therapy, radiation therapy, exercise therapy, diet, supportive care, behavioral therapy, information on medications (including herbal medicines and supplements), prognosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Fasting (fasting for 36 to 48 hours) in a facility supervised by a physician. During the fasting period, blood glucose levels will be constantly monitored using a continuous glucose meter. During the fasting period, patients are allowed to drink water and take salt, and are offered a diet of 100 to 200 kcal/day. Oral medications are also allowed (however, diabetic medications should be discussed with the patient's physician as appropriate). The amount of fluid required for each patient should be calculated, and the patient should be encouraged to drink as the minimum daily fluid intake (fluid requirement (ml/day) = body weight (kg) x fluid requirement by age (ml/kg/day) 22-54 years: 35 ml/kg per day 55-64 years: 30 ml/kg per day 65 years and older: 25 (ml/kg/day).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. be 20 years of age or older at the time of consent
2. who are able to visit the Department of Urology, Juntendo University Hospital, Juntendo University School of Medicine, or who are able to visit the hospital
3. who have received a full explanation of their participation in this study, and who have given their consent of their own free will based on a thorough understanding of the study
Key exclusion criteria
Those who could not obtain consent.
Those who are under 20 years of age at the time of obtaining consent.
Systemic infection, acute or chronic viral hepatitis, diabetes mellitus with poor glycemic control, serious renal or hepatic dysfunction, serious cardiovascular or cerebrovascular disease within 6 months, serious gastrointestinal disease or gastric surgery within 12 months, active malignancy within 5 years, current or planned pregnancy, lactation.
Persons deemed inappropriate as research subjects by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Horie |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Urology
Zip code
113-0033
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
shorie@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ikehata |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Urology
Zip code
113-0033
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
y-ikehata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Shigeo Horie
Funding Source
Organization
Juntendo University
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
Juntendo University, Graduate School of Medicine
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.ac.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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 27 | 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
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060385
