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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000042602 |
Receipt No. | R000048625 |
Scientific Title | Examination of the effect of single intake of test food on satiety: a crossover trial. |
Date of disclosure of the study information | 2020/11/30 |
Last modified on | 2020/12/10 |
Basic information | ||
Public title | Examination of the effect of single intake of test food on satiety: a crossover trial. | |
Acronym | Examination of the effect of single intake of test food on satiety. | |
Scientific Title | Examination of the effect of single intake of test food on satiety: a crossover trial. | |
Scientific Title:Acronym | Examination of the effect of single intake of test food on satiety. | |
Region |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the effects of single intake of test foods on satiety in female aged 30 to under 50 years old. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Questionnaire (VAS) |
Key secondary outcomes | Leptin, ghrelin, CCK, insulin, glucose (in blood) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -investigator(s) and assessor(s) 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 | Take the test food once | |
Interventions/Control_2 | Take the placebo food once | |
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 | Female | |||
Key inclusion criteria | 1. Aged 30 to 49 years old at the time of informed consent
2. Japanese female 3. BMI less than 30 4. Those who receive explanations of the clinical trial in advance and obtain written consent by themselves |
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Key exclusion criteria | 1. Those who are currently receiving any types of medicines and/or Chinese medical treatment (except for the drugs taken as needed)
2. Those who have severe liver, kidney, heart, respiratory, endocrine, metabolic diseases, etc. 3. Those who have a history of treatment for heart failure, myocardial infarction, etc. 4. Those who have had gastrointestinal surgery (however, appendicitis is acceptable) 5. Those who are taking health foods (foods or supplements that affect body composition or are intended to maintain or restore health) 6. Those who smoke excessively (21 or more cigarettes / day) 7. Those who drink excessive alcohol (alcohol equivalent 60g or more / day) 8. Those who have or have a history of drug allergies or food allergies 9. Those who work in shifts, such as those who work night shifts 10. Those who are planning to travel abroad, such as traveling abroad, during the test period 11. Those who wish to become pregnant, breastfeeding or during the test period 12. Those who have participated in or are currently participating in other clinical trials within one month before obtaining consent, or those who plan to participate during the trial period 13. Those who are judged by the investigator to be unsuitable for participation in this study |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | integrate co., ltd. | ||||||
Division name | Business Development Department | ||||||
Zip code | 151-0051 | ||||||
Address | 1-20-1 Sendagaya Shibuya-ku Tokyo | ||||||
TEL | 03-5771-5514 | ||||||
y.kohama@itgr.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | IMEQRD inc. | ||||||
Division name | Sales department | ||||||
Zip code | 104-0061 | ||||||
Address | 6-2-1 Ginza Chuo-ku Tokyo | ||||||
TEL | 03-6704-5968 | ||||||
Homepage URL | |||||||
h-kayama@imeqrd.co.jp |
Sponsor | |
Institute | IMEQRD inc. |
Institute | |
Department |
Funding Source | |
Organization | Fujicco 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 | Suda Clinic institutional review board |
Address | 2-8-14,Takadanobaba,Shinjyuku,Tokyo |
Tel | 03-3207-8161 |
suda-clinic_irb@imeq.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 | No longer 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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048625 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |