UMIN-ICDS Clinical Trial

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

healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES

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

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

Study type

Interventional

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

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

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

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

Email

shorie@juntendo.ac.jp

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

Email

y-ikehata@juntendo.ac.jp

Institute

Juntendo University

Institute

Department

Personal name

Shigeo Horie

Organization

Juntendo University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Juntendo University, Graduate School of Medicine

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

Tel

03-3813-3111

Email

hongo-rinri@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂大学医学部附属順天堂医院

Date of disclosure of the study information

2023

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000060385