UMIN-CTR Clinical Trial

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 inc.
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 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
Email	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	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	No longer recruiting
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	2020 Year 12 Month 10 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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