UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042602 |
|---|---|
| Receipt number | 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 | 2021/02/17 18:53:16 |
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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
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
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
| Food |
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
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
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
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kohama |
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
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
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 or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
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
03-6704-5968
n-yuzawa@imeqrd.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
| 2020 | Year | 11 | Month | 30 | 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
| 2020 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048625
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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