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Name:
UMIN ID:

Recruitment status Completed
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 2021/02/17

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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
Email 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
Email h-kayama@imeqrd.co.jp

Sponsor
Institute IMEQRD Co., Ltd
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 03-6704-5968
Email 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
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


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