UMIN-CTR Clinical Trial

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