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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000047663 |
Receipt No. | R000054324 |
Scientific Title | Tests on satiety |
Date of disclosure of the study information | 2022/05/06 |
Last modified on | 2022/05/07 |
Basic information | ||
Public title | Tests on satiety | |
Acronym | Tests on satiety | |
Scientific Title | Tests on satiety | |
Scientific Title:Acronym | Tests on satiety | |
Region |
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Condition | |||
Condition | None | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 22 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | APO PLUS STATION CO., LTD. |
Institute | |
Department |
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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054324 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |