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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037132
Receipt No. 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 2019/12/23

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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 level
Key secondary outcomes Blood glucose area under the curve during oral glucose tolerance test, 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
Email 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
Email shimamura@m-health-lab.jp

Sponsor
Institute Matsumoto Junior College
Institute
Department

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
Email 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 No longer recruiting
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
Date trial data considered complete
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
2019 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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