UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037132 |
|---|---|
| Receipt number | R000042318 |
| Scientific Title | Effects of ingredient obtained from plant on glucose metabolism in healthy adult: a randomized, double-blind, parallel-group, placebo-controlled study |
| Date of disclosure of the study information | 2019/07/22 |
| Last modified on | 2021/02/19 11:26:26 |
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Basic information
Public title
Effects of ingredient obtained from plant on glucose metabolism in healthy adult: a randomized, double-blind, parallel-group, placebo-controlled study
Acronym
Effects of ingredient obtained from plant on glucose metabolism (Matsumoto-GM study).
Scientific Title
Effects of ingredient obtained from plant on glucose metabolism in healthy adult: a randomized, double-blind, parallel-group, placebo-controlled study
Scientific Title:Acronym
Effects of ingredient obtained from plant on glucose metabolism (Matsumoto-GM study).
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the ingredient obtained from plant on glucose metabolism in healthy adult.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose area under the curve during oral glucose tolerance test
Key secondary outcomes
Blood glucose level, HbA1c, serum insulin, HOMA-IR, glycoalbumin, Matsuda Index, blood biochemistry, physical examination.
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food (3 capsules/day, 12 weeks)
Interventions/Control_2
Intake of control food (3 capsules/day, 12 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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects aged from 20 to 74 years old.
2) Subjects who shows a fasting blood glucose level from 100 to 125 mg/dL, and/or 2-hour blood glucose level from 140 to 199 mg/dL after OGTT.
Key exclusion criteria
1) Subject who have serious disease or medical history in brain, liver, kidney, heart, lung, gastrointestinal tract, blood, or endocrine metabolism, etc.
2) Subject who regulartory food or supplement improving the blood glucose levels.
3) BMI levels of over 30.0 kg/m2
4) Subject who are pregnent or under lactation. or who is expected to be pregnant during the study.
5) Subject who have a medical history of serious allergy to medicine and food.
6) Subject who excessively take alcohol.
7) Subject who is smoker (smoking over 20 cigarettes/day)
8) Participants in other clinical trials.
9) Subjects who are judged unsuitable for participating in this study by principal investigator physician.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Mitsunaga |
| Middle name | |
| Last name | Miyasaka |
Organization
Matsumoto Junior College
Division name
Department of Nursing
Zip code
399-0033
Address
3118, Sasaga, Matsumoto, Nagano, Japan
TEL
0263-58-4417
mjc-m.miyasaka@matsutan.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Shimamura |
Organization
Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
Homepage URL
shimamura@m-health-lab.jp
Sponsor or person
Institute
Matsumoto Junior College
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY 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
Matsumoto Junior College
Address
3118, Sasaga, Matsumoto, Nagano, Japan
Tel
0263-58-4417
mjc-m.miyasaka@matsutan.ac.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 | 22 | 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
| 2019 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 05 | Day |
Date analysis concluded
Other
Other related information
In advance to this trial, blood chemistry examination, physical measurement and life style survey will be conducted in adults who lives in Matsumoto city and participant in the screening test of this trial will be selected.
Management information
Registered date
| 2019 | Year | 06 | Month | 21 | Day |
Last modified on
| 2021 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042318
