UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039470 |
|---|---|
| Receipt number | R000044998 |
| Scientific Title | Two-group, parallel, double-blind study to evaluate the effects of limonite intake on glucose metabolism during 12 weeks. |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/08/17 11:13:08 |
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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
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
info@ksk-lab.co.jp
Sponsor or person
Institute
Mie University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044998
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| Registered date | File name |
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