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 : Randomised double-blind placebo-controlled trial
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 : Randomised 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 ingesting glucose.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose *Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.
Key secondary outcomes	Insulin *Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.

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	Food containing test food + glucose 75 g, single ingestion [Wash out for 1 week] Food not containing test food + glucose 75 g, single ingestion
Interventions/Control_2	Food not containing test food + glucose 75 g, single ingestion [Wash out for 1 week] Food containing test food + glucose 75 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) Males and females, aged 20 - 65 years old. 2) Subjects whose fasting blood glucose level is from 110 mg/dL to 125 mg/dL or two-hour blood glucose level after 75 g glucose loading is from 140 mg/dL to 199 mg/dL, and who are judged normal-high or borderline type as the state of glycemia by the principal investigator. 3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	1) Subjects whose fasting blood glucose level is greater than or equal to 126 mg/dL and two-hour blood glucose level after 75 g glucose loading is greater than or equal to 200 mg/dL. 2) A medical history of malignant tumor, heart failure or myocardial infarction. 3) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4) Subjects who currently taking medications (including herbal medicines) 5) Subjects who are allergic to medications and/or the test food related products. 6) Subjects with irregular life rhythms such as shift workers, irregular eating habits. 7) Subjects who are pregnant, breast-feeding, or planning to get pregnant. 8) Subjects who have been enrolled in other clinical trials within the last 4 weeks before the agreement to participate in this trial. 9) Subjects who are considered as ineligible to participate in the study by the physician.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasutaka Middle name Last name Makishima
Organization	Allegro Inc.
Division name	Clinical trial promotion department
Zip code	151-0051
Address	4F, BML Bldg. 5-21-3, Sendagaya, Shibuya-ku, Tokyo
TEL	03-5363-6821
Email	y-maki@bml.co.jp

Public contact
Name of contact person	1st name Fumiko Middle name Last name Kase
Organization	Allegro Inc.
Division name	Clinical trial promotion department
Zip code	151-0051
Address	4F, BML Bldg. 5-21-3, Sendagaya, Shibuya-ku, Tokyo
TEL	03-5363-6821
Homepage URL
Email	f-kase@bml.co.jp

Sponsor
Institute	Allegro Inc.
Institute
Department

Funding Source
Organization	Pharma Foods International Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	MC Food Specialties Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tomisaka Clinic
Address	1-33-9, Hongo, Bunkyo-ku, Tokyo
Tel	03-3814-2662
Email	info@tomisaka.or.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	2019 Year 03 Month 18 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	2019 Year 02 Month 21 Day
Date of IRB	2019 Year 03 Month 13 Day
Anticipated trial start date	2019 Year 03 Month 18 Day
Last follow-up date	2019 Year 05 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	2019 Year 03 Month 18 Day
Last modified on	2020 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041281