UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the effect of exercise using an ultra-soft rubber band on postprandial blood glucose after eating cooked rice
Acronym	Verification of the effect of exercise using an ultra-soft rubber band on postprandial blood glucose after eating cooked rice
Scientific Title	Verification of the effect of exercise using an ultra-soft rubber band on postprandial blood glucose after eating cooked rice
Scientific Title:Acronym	Verification of the effect of exercise using an ultra-soft rubber band on postprandial blood glucose after eating cooked rice
Region	Japan

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

Objectives
Narrative objectives1	Without placing a heavy load on the muscles, easily exercise using ultrasonic soft rubber band that can move the muscles by performing after meals, verifies that spikes in blood glucose level after meals (blood sugar level spike) can be suppressed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in blood glucose level and AUC / iAUC / Cmax / Tmax
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Visit-1 No intervention Visit-2 Exercise full set using ultra-soft rubber band size L(10 minutes) Visit-3 Exercise full set using ultra-soft rubber band size S(10 minutes) Visit-4 Exercise half set using ultra-soft rubber band size S(6 minutes)
Interventions/Control_2
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	45 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Aged between 45 and 65 [2]Individuals who are healthy and do not treat any disease [3]Individuals whose written informed consent has been obtained [4]Individuals who can have an examination on a designated check day [5]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals under treatment or with history of lipid metabolism abnormality,hypertension, diabetes, mental disorders, sleep disorders, or other serious disorders [3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it.) [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease [5]Individual who have digestive organ disease(disease of an appendix is removed) [6]Individuals with abnormal ECGs [7]Individuals whose BMI is less than 18.5 kg/m2 or over 30 kg/m2 [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [9]Individuals with serious anemia [10]Individuals who have difficulty collecting blood over time [11]Individuals with daily exercise habits [12]Individuals who have difficulty exercising for 10 minutes [13]Individual who is based on average alcohol per 1 day and exceeds 60g/day [14]Individuals whose life style will change during the test period (ex. travel for a long time) [15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments of glycometabolism in the past 3 month or will ingest those foods during the test period [16]Individual who is pregnant or lactate [17]Individuals who participated in other clinical studies in the past three months [18]Individuals judged inappropriate for the study by the principal
Target sample size	14

Research contact person
Name of lead principal investigator	1st name Yoshikazu Middle name Last name Yonei
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Anti-Aging Medical Research Center
Zip code	610-0394
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	1st name Toshiyasu Middle name Last name Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
Zip code	1100015
Address	6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo
TEL	03-6801-8400
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	Anti-Aging Bank Co.,Ltd.
Institute
Department

Funding Source
Organization	Kyowa Rubber 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	Society of Glycative Stress Research
Address	5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel	03-6709-8842
Email	rinri-glycativestress@antiaging-bank.com

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	うえのあさがおクリニック

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 20 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	14
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 12 Month 26 Day
Date of IRB	2020 Year 01 Month 09 Day
Anticipated trial start date	2020 Year 01 Month 20 Day
Last follow-up date	2020 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	2020 Year 01 Month 15 Day
Last modified on	2020 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044655