UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level
Acronym	A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level
Scientific Title	A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level: Randomized double-blind placebo-controlled trial
Scientific Title:Acronym	A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of test food intake on the suppression of the elevation of postprandial blood glucose after meal.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- Blood glucose *Measure at before ingestion and 15, 30, 45, 60, 90, and 120 minutes after ingestion. - Area Under the Curve
Key secondary outcomes

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	Food
Interventions/Control_1	1)Test food + rice 200 g, single ingestion 2)Wash out for 1 week 3)Placebo food + rice 200 g, single ingestion
Interventions/Control_2	1)Placebo food + rice 200 g, single ingestion 2)Wash out for 1 week 3)Test food + rice 200 g, single ingestion
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Japanese male and female aged 20-64 years old at the time of the informed consent 2) Subjects whose fasting blood glucose level is less than 126 mg/dL or two-hour blood glucose level after 75 g glucose loading is less than 200 mg/dL at the screening test. 3) Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1)Subject who is considered as a diabetes by a doctor. 2)Subject who is taking medication or under medical treatment. 3)Subject who is under exercise therapy or dietetic therapy. 4)Subject who has an allergy for test food. 5)Subject who has or had a history of either medicine or alcohol dependence syndrome. 6)Subject who has or had a history of mental illness(depression) or sleep disturbance. 7)Subject who is on a night-shift or is a shift worker. 8)Subject whose lifestyle is extremely irregular. 9)Subject who has an unbalanced diet. 10)Subject who is current disease or history of brain disorder, cancer, immunity disorder, diabetes, liver disease(hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases. 11)Subject who is use health foods, supplements, and medicines that may affect diabetes. 12)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 13)Subject who has blood drawn 200 mL within the past 1 months or 400 mL within the past 3 months from the day of the consent acquisition. 14)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 15)Subject who can't keep the daily records. 16)Subject who is judged as an inappropriate candidate according to the screening data. 17)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Yamatsu
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development
Zip code	615-8245
Address	1-49, Goryo-ohara, nishikyo-ku, Kyoto city, Kyoto, Japan
TEL	075-748-9829
Email	a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	Pharma Foods International Co., Ltd.
Institute
Department

Funding Source
Organization	Mitsubishi Corporation Life Sciences Limited
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	the ethics committees of Yoga Allergy Clinic
Address	4-32-16, Yoga, Setagaya-ku, Tokyo, Japan
Tel	03-5491-4478
Email	jim@medipharma.co.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	FH19-001
Org. issuing International ID_1	HUMA R&D CORP
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	とうきょうスカイツリー駅前内科

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 15 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	Preinitiation
Date of protocol fixation	2021 Year 01 Month 29 Day
Date of IRB	2021 Year 02 Month 12 Day
Anticipated trial start date	2021 Year 02 Month 15 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 14 Day
Last modified on	2021 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049458

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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