UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effects of test food on glucose behavior in human
Acronym	A study on the effects of test food on glucose behavior in human
Scientific Title	A study on the effects of test food on glucose behavior in human
Scientific Title:Acronym	A study on the effects of test food on glucose behavior in human
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of test food on glucose behavior in human.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose levels, persistently measured by FreeStyle Libre Sensor (Abbott).
Key secondary outcomes	Questionnaire : Sense of hunger Glycometabolism : HbA1c, FBS Liver function : ALT, AST, Gamma-GTP, Total Bilirubin, Albumin, ALP Renal function : Serum Creatinine Serum lipid : TC, TG, LDL-C, HDL-C, RLP-C Anthropometry : Weight, Abdominal circumference, Blood pressure, Body fat percentage, Physical activity

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	Treatment
Type of intervention	Food
Interventions/Control_1	Consume one test food a day (for 3day)->Washout (for 4 days) -> Consume one placebo food a day (for 3day)
Interventions/Control_2	Consume one placebo food a day (for 3day)-> Washout (for 4 days) -> Consume one test food a day (for 3day)
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1.Healthy volunteer 2.Males and females aged between 20 and 59. 3. Subjects who receive adequate explanation for participation in this research and provide informed consent in writing by their own free will. 4. Subjects who can take certainly foods according to instructions, and understand how to use wearable blood glucose monitoring equipment and wearable physical activity meter. Subjects who can write Life diary and Questionnaire. 5. Subjects who are judged suitable for this study by principal investigator and doctors.
Key exclusion criteria	1. Subjects with diabetes or borderline diabetes. 2. Subjects who fall under any of the following: ALT>200 IU/L, AST>200 IU/L, Gamma-GTP>200 IU/L, Total Bilirubin>2.0g/dl. 3. Subjects who are suspected acute and subacute hepatopathy. 4. Subjects with serious heart problems. 5. Subjects with renal dysfunction (serum creatinine > 2.0 mg/dL). 6. Subjects with tumor bearing. 7. Subjects who can't take medication according to instructions. 8. Subjects who had serious disease or have disease in treatment, and who are judged not to be suitable for this study. 9. Subjects with risk of allergy related to this study. 10. Subjects who have symptoms such as fever, sore throat, cough, diarrhea, vomiting etc and are suspected acute infectious diseases. 11. Subjects who participated in other clinical trials within 2 months. 12. Subjects who continuously take dietary fiber or supplements, foods for specified health use , that contain substances affecting blood glucose levels. 13. Subjects who are judged unsuitable for this study by principal investigator and doctors.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Nishizaki
Organization	Tokai University School of Medicine
Division name	Dept. of Clinical Health Science
Zip code	151-0053
Address	1-2-5 Yoyogi, Shibuya-ku, Tokyo, Japan Tokai University Tokyo Hospital
TEL	03-3370-2321
Email	y-nishizaki@tokai.ac.jp

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Nishizaki
Organization	Tokai University School of Medicine
Division name	Dept. of Clinical Health Science
Zip code	151-0053
Address	1-2-5 Yoyogi, Shibuya-ku, Tokyo, Japan Tokai University Tokyo Hospital
TEL	03-3370-2321
Homepage URL
Email	y-nishizaki@tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Mizkan 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	Institutional Review Board for Clinical Research, Tokai University
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.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 07 Month 24 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	29
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 07 Month 24 Day
Date of IRB	2019 Year 08 Month 01 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2020 Year 02 Month 29 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 07 Month 24 Day
Last modified on	2020 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042710