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. -Randomised double-blind placebo-controlled trial
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. -Randomised double-blind placebo-controlled trial
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 level after ingesting rice meal.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time course of blood glucose level and AUC (area under the curve)(0-2hrs).
Key secondary outcomes	Time course of blood insulin level and AUC (area under the curve)(0-2hrs).

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	Test participants intake one package of test food dissolved in 180ml water 15 min before consuming rice meal.
Interventions/Control_2	Test participants intake one package of control food dissolved in 180ml water 15 min before consuming rice meal.
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 to 64 years old when informed consent and body mass index (BMI) is included between 18.5 to less than 30 (2)Individuals who fasting blood glucose level at the time of screening is 100 mg/dl or more 125 mg/dl or less, or glucose load test 2 hours after glucose level is 140 mg/dl or more 199 mg/dl or less, individuals who are judged to normal high blood glucose level or borderline diabetes by the principal investigator (3)Individuals who do not drink large amount of alcohol habitually (4) Individuals who are judged that not suffering from a disease (5)Individuals giving written informed consent
Key exclusion criteria	(1) Individuals whose fasting blood glucose level at the time of screening is 126mg/dl or more, or glucose level is 200mg/dl or more 2 hours after the glucose load test (2)Individuals who use oral medication affecting blood glucose level (3)Individuals who constantly use supplements and/or functional foods, including food for specified health use and/or food with function claims, affecting blood glucose level (4)Individuals who were judged to be diagnosed with diabetes at the screening checkup (5)Individuals who are suffering from or under treatment of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder (6) Individuals who have a chronic disease and use medicines continuously (7)Individuals who have a history of digestive disease and/or surgical history affecting digestion and absorption , have a disorder such as stenosis in the gastrointestinal tract (8)Individuals who had an onset diarrhea within one week from the date of screening, and who is prone to diarrhea always (9)Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (10) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	niho-jimucho@well-sleep.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshika Komori
Organization	KSO Corporation
Division name	Sales department
Zip code
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Nissin Foods Holdings 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
Address
Tel
Email

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 01 Month 11 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	2018 Year 12 Month 07 Day
Date of IRB	2018 Year 12 Month 05 Day
Anticipated trial start date	2019 Year 01 Month 12 Day
Last follow-up date	2019 Year 02 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 21 Day
Last modified on	2019 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040256