UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050667 |
|---|---|
| Receipt number | R000057726 |
| Scientific Title | A study of the effects of fasting and supplementation on glucose and lipid metabolism |
| Date of disclosure of the study information | 2023/03/24 |
| Last modified on | 2023/07/19 09:17:06 |
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Basic information
Public title
A study of the effects of fasting and supplementation on glucose and lipid metabolism
Acronym
A study of the effects of fasting and supplementation on glucose and lipid metabolism
Scientific Title
A study of the effects of fasting and supplementation on glucose and lipid metabolism
Scientific Title:Acronym
A study of the effects of fasting and supplementation on glucose and lipid metabolism
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the biochemical and psychological effects of a 4-day/3-night fasting program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total cholesterol, LDL, HDL, triglycerides, oxidized LDL, adiponectin, glucose, glycoalbumin, HbA1c,insulin, HOMA-IR
Measure at before and after intervention.
Key secondary outcomes
Telomere length, G-tail length, protein, albumin, AST, ALT, Ca, Mg, Fe, Cu, ferritin, zinc, EPA, DHA, EPA/AA ratio, DHA/AA ratio, (EPA+DHA)/AA ratio, CRP, IL-6, TNFalpha, Hb, Ht, MCV, MHC, MCHC, systolic blood pressure, diastolic blood pressure, OSA-MA sleep quality test, POMS stress test, heavy metal mineral test, urinary 8-OHdG, height, weight, BMI, lean body mass
Measure at before and after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Participation in a 3-night 4-day fasting program
Then, take 3 supplements for 31 days.
Interventions/Control_2
Take 3 supplements for 34 days.
Interventions/Control_3
Non-intervention
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese who are 40 years old or under 64 years old
2) Persons who are healthy and do not have chronic physical or mental illnesses
3) Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
4) Persons with a BMI of 22 or higher
5) Persons who can come to the clinic on the designated day and undergo the examination
6) Persons who have been deemed suitable for participation in this study by the responsible physician.
Key exclusion criteria
1) Persons who are currently suffering from some kind of disease and are judged by the investigator to need treatment
2) Persons with a history or current illness of severe disorders including liver, kidney, heart, lung, blood, digestive system, etc.
3) Persons with alcohol dependence or other mental disorders
4) Persons with a habit of taking medication for treatment of illness within the past month (excluding occasional use of medication for headache, menstrual pain, cold, etc.)
5) Persons who may develop seasonal allergy symptoms during the trial period, specific allergens include: Hanoki, Oobayashabushi, birch, sugi, hinoki, ragweed, mugwort, orchardgrass, and timothy grass
6) Persons who may experience allergic reactions to the ingredients in the test food, or those who may experience severe allergic reactions to other food or medication
7) Persons with severe anemia
8) Persons prone to contact dermatitis, those who have had it in the past, or those with sensitive fingertips
9) Persons who have a smoking habit
10) Women who are pregnant, nursing, planning to become pregnant during the trial period, or planning to become pregnant during the trial period
11) Persons who may change their lifestyle during the trial period (e.g., night shift work, long-term travel, etc.)
12) Persons who have habitually consumed functional food, health food, supplements containing ingredients of the test food within the past 3 months or plan to consume them during the trial period.
13) Persons who have received treatment requiring hospitalization within the past 6 months.
14) Persons who participate in other clinical studies or participated in the last 3 months or plan to participate in other clinical studies.
15) Persons who are judged by the investigator to be inappropriate for this study.
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Ito |
Organization
Akasaka Family Clinic
Division name
Clinic Director
Zip code
107-0052
Address
Akasaka Plaza Bld. 3F, 15-15 Akasaka, Minato-ku, Tokyo, JAPAN
TEL
03-5562-8825
info@afc.tokyo
Public contact
Name of contact person
| 1st name | Mitsuko |
| Middle name | |
| Last name | Ito |
Organization
Akasaka Family Clinic
Division name
Clinic Director
Zip code
107-0052
Address
Akasaka Plaza Bld. 3F, 15-15 Akasaka, Minato-ku, Tokyo, JAPAN
TEL
03-5562-8825
Homepage URL
info@afc.tokyo
Sponsor or person
Institute
Akasaka Family Clinic
Institute
Department
Personal name
Funding Source
Organization
ARSOA KEIO GROUP CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2023 | Year | 03 | Month | 24 | 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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 22 | 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 | 03 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057726
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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