UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047663 |
|---|---|
| Receipt number | R000054324 |
| Scientific Title | Tests on satiety |
| Date of disclosure of the study information | 2022/05/06 |
| Last modified on | 2022/11/11 15:37:20 |
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Basic information
Public title
Tests on satiety
Acronym
Tests on satiety
Scientific Title
Tests on satiety
Scientific Title:Acronym
Tests on satiety
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To preliminarily confirm the effect of satiety on the consumption of the test food in healthy adult males by a randomized, double-blind, placebo-controlled, crossover comparative study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satiety VAS
Key secondary outcomes
Dietary intake (dietary intake group only)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of test food
Interventions/Control_2
Single intake of placebo food
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1) Japanese males between the ages of 20 and 60 years old at the time consent is obtained.
2) Persons with no abnormal blood glucose levels (those who have never had abnormal blood glucose levels indicated in a medical checkup)
3) Persons with a BMI between 18.5 kg/m2 and 22.0 kg/m2
4) Persons who have received a full explanation of the purpose and content of the study and who have signed a consent form prior to the start of the study.
Key exclusion criteria
1) Those who have a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic diseases.
2) Those who are currently undergoing treatment for a serious illness.
3) Persons with food allergies or those who may develop allergies related to the tested food items.
4) Persons who regularly use medicines or quasi-drugs that may affect the test items.
5) Persons who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items.
6) Those who are unable to discontinue the intake of pharmaceuticals (excluding intravenous medication), quasi-drugs, or health foods (food for specified health uses, nutritional supplements, foods with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study.
7) Those whose lifestyle is extremely irregular (e.g., working at night or living day and night in reverse)
8)Persons who are unable to maintain their daily lifestyle (e.g., exercise and drinking habits)
9) Persons who have difficulty consuming the test food as directed.
10) Other subjects who are judged by the investigator to be unsuitable for the study.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakamura |
Organization
Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Division name
department of internal medicine
Zip code
103-0025
Address
1-9-2 Nihonbashikayabacho, Chuo-ku, Tokyo
TEL
0366619061
mail-1@ouryokukai.sakura.ne.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operation Department, CRO Business Division
Zip code
103-0027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo, Japan
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ANGFA Co.,Ltd.
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
Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Address
1-9-2 Nihonbashikayabacho, Chuo-ku, Tokyo
Tel
03-6661-9061
c-irb_ug@neues.co.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
| 2022 | Year | 05 | Month | 06 | 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
| 2022 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054324
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
