UMIN-CTR Clinical Trial

Basic information
Public title	Effect of a Food Material on Blood Glucose Level
Acronym	Effect of a Food Material on Blood Glucose Level
Scientific Title	Effect of a Food Material on Blood Glucose Level
Scientific Title:Acronym	Effect of a Food Material on Blood Glucose Level
Region	Japan

Condition
Condition	No
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effect of a food material on blood glucose level.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose level on glucose tolerance test (75g OGTT) (Screening, Week 0, Week 4:before glucose tolerance test, 30, 60, 90, and 120 minutes after glucose tolerance test).
Key secondary outcomes	*Secondary indexes [1]Indexes for blood glucose in fasting(2). [2]Insulin on glucose tolerance test (75 OGTT)(2,5). [3]Insulinogenic Index(2). [4]Indexes for lipid in fasting(2). *Indexes for exploratory research [1]Watch-type device survey(4). [2]Questionnaire survey(3). *Safety [1]Blood pressure, pulsation(2). [2]Weight, body fat percentage, BMI(2). [3]Subject's diary(4). [4]Doctor's questions(2). [5]Adverse events: number of cases and expression rate of adverse events(3). *Other indexes [1]Hematologic test(1). [2]Blood biochemical test(1). [3]Urine analysis(1). (1):Screening. (2):Screening, Week 0, Week 4. (3):Week 0, Week 4. (4)From the first day of ingestion of a test material to the last day of the test. (5)Screening, 30, 60, 90, and 120 minutes after glucose intake.

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of the test food (1 capsule / day; 4 weeks).
Interventions/Control_2	Oral intake of the placebo food (1 capsule / day; 4 weeks).
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	40 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	[1] ]Healthy Japanese males and females aged 40-64 years. [2]Individuals with borderline type or elevated postprandial blood glucose levels in glucose tolerance test (75 g OGTT) [3]Individuals who are healthy and have no chronic physical disease including skin disease. [4]Individuals whose written informed consent has been obtained. [5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals who use or used a drug to treat a disease in the past 1 month. [2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3]Individuals whose fasting blood glucose is over 126mg/dL. [4]Individuals whose two-hour glucose level is over 200 mg/dL in glucose tolerance test. [5]Individuals whose HbA1c is over 6.5%. [6]Individuals whose BMI is less than 18.5kg/m2 or over 30kg/m2. [7]Individuals who excessively take alcohol. [8]Individuals who are a smoker. [9]Individuals who have irregular lifestyles and eating habits, and may change their lifestyles during the test period. [10]Individuals who experienced unpleasant feeling during blood drawing. [11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [12]Individuals who ingest regularly foods for specified health uses, health foods, or foods with functional claims which may be affect the test in the past 3 months or will use or ingest those foods during the test period. [13]Individuals who may have allergic symptoms to test foods and designated meal, and Individuals who may have serious allergic symptoms to other foods. [14]Individuals who fall under any of the following criteria when using a wrist-watch device. Individuals (1) With illness or heart disease, (2) With photosensitive medication, (3) who have epilepsy or are sensitive to flashing lights, (4) with poor blood circulation or who bruise easily, (5) with tendonitis, carpal tunnel syndrome, or other musculoskeletal disorders, and (6) who may have allergic symptoms to metals. [15]Individuals who participated in other clinical studies in the past 3 months. [16]Individuals who are or are possibly pregnant, or are lactating. [17]Individuals judged inappropriate for the study by the principal.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals 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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81528382485
Email	i.takahashi@tes-h.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	2021 Year 06 Month 10 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	2021 Year 05 Month 17 Day
Date of IRB	2021 Year 05 Month 19 Day
Anticipated trial start date	2021 Year 07 Month 02 Day
Last follow-up date	2021 Year 08 Month 06 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 06 Month 09 Day
Last modified on	2022 Year 06 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050581