UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039165 |
|---|---|
| Receipt number | R000044655 |
| Scientific Title | Verification of the effect of exercise using an ultra-soft rubber band on postprandial blood glucose after eating cooked rice |
| Date of disclosure of the study information | 2020/01/20 |
| Last modified on | 2020/07/15 11:27:07 |
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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
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
info@tes-h.co.jp
Sponsor or person
Institute
Anti-Aging Bank Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044655
