UMIN-CTR Clinical Trial

Basic information
Public title	Two-group, parallel, double-blind study to evaluate the effects of limonite intake on glucose metabolism during 12 weeks.
Acronym	Sugar metabolism test.
Scientific Title	Two-group, parallel, double-blind study to evaluate the effects of limonite intake on glucose metabolism during 12 weeks.
Scientific Title:Acronym	Sugar metabolism test.
Region	Japan

Condition
Condition	Healthy person (high fasting blood glucose level, up to 125 mg / dl)
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect on glucose metabolism after 12 weeks of ingestion of limonite by adult men and women with normal fasting blood glucose level.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glucose metabolism (comparison of changes in fasting blood glucose level from the initial value at 12 weeks)
Key secondary outcomes	Glucose metabolism (fasting blood glucose levels other than primary outcomes, HbA1c, insulin), iron (serum ferritin, serum iron, TIBC (iron binding ability)), intestinal flora (intestinal flora, defecation frequency), safety

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test substance (300 mg limonite, taken every morning for 12 weeks)
Interventions/Control_2	Control substance (potato starch 300 mg, taken every morning for 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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Men and women aged between 20 and 80 at the time of consent acquisition 2) Fasting blood glucose level 100-125mg / dl (not diabetes) 3) Persons who can take in foods and pharmaceuticals that affect the intestinal flora, such as lactic acid bacteria at the time of registration, can be taken continuously during the test period 4) Participants who have been given sufficient explanations and have given their informed consent with sufficient understanding after participating in this clinical trial
Key exclusion criteria	1) HbA1c value measured during the observation period exceeded 6.5 2) Persons who do not take iron preparations or supplements or drugs intended to take iron (meaning iron 10 mg / day or heme iron more than 100 mg/day) 3) A person who is judged by the doctor to have high blood pressure based on the blood pressure measured during the observation period. (If the measured value exceeds 200 mmHg at the time of visit, the doctor who interviews and judges three times.) 4) Patients who go to the hospital regularly and need to be treated with medicines such as oral medicines (Glucose tolerance and intestinal flora are not affected and transient ones are not excluded. Example: Cold, Transient dermatitis, etc.,Exclude hospital visits due to chronic illness with or without effects) 5) Patients who are judged by the investigator or investigator to be inappropriate as subjects
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Gabazza Middle name C Last name Esteban
Organization	Mie University, Graduate School of Medicine
Division name	Department of Immunology
Zip code	514-8507
Address	2-174 Edobashi, Tsu, Mie
TEL	059-231-5037
Email	gabazza@doc.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Umeda
Organization	KSK Laboratories,Inc.
Division name	representative
Zip code	514-0027
Address	t.c.p 4F,7-15 Daimon, Tsu, Mie
TEL	059-253-8091
Homepage URL
Email	info@ksk-lab.co.jp

Sponsor
Institute	Mie University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	tanisake 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	Mie University Hospital Clinical Research Ethics Review Committee
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel	059-231-5261
Email	s-kikaku2@mo.medic.mie-u.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	2020 Year 04 Month 01 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	Terminated
Date of protocol fixation	2020 Year 01 Month 22 Day
Date of IRB	2020 Year 02 Month 19 Day
Anticipated trial start date	2022 Year 08 Month 07 Day
Last follow-up date	2023 Year 12 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 02 Month 13 Day
Last modified on	2022 Year 08 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044998