UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057148 |
|---|---|
| Receipt number | R000065326 |
| Scientific Title | A Confirmation Study for the Effect of Promoting Urinary Glucose Excretion by Ingestion of Test Foods -Placebo-controlled, double-blind, single-dose crossover controlled study- |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 17:57:48 |
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Basic information
Public title
Test to confirm the effect of ingesting food to promote urinary glucose excretion
Acronym
Test to confirm the effect of ingesting food to promote urinary glucose excretion
Scientific Title
A Confirmation Study for the Effect of Promoting Urinary Glucose Excretion by Ingestion of Test Foods -Placebo-controlled, double-blind, single-dose crossover controlled study-
Scientific Title:Acronym
A Confirmation Study for the Effect of Promoting Urinary Glucose Excretion by Ingestion of Test Foods -Placebo-controlled, double-blind, single-dose crossover controlled study-
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effect of the test food on promoting glucose excretion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary glucose
Key secondary outcomes
Urinary sodium, urinary uric acid
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
[1] Designated food intake (number of intakes: 8 times)
[2] Animal Urine Measurement
[3] Ingestion of test food B (number of intakes: 1 time)
[4] Washout (2 weeks)
[5] Designated food intake (number of intakes: 8 times)
[6] Animal Urine Measurement
[7] Ingestion of test food A (number of ingestions: 1 time)
[8] Washout (2 weeks)
[9] Designated food intake (number of intakes: 8 times)
[10] Animal Urine Measurement
[11] Ingestion of placebo food (number of intakes: 1 time)
Interventions/Control_2
[1] Designated food intake (number of intakes: 8 times)
[2] Animal Urine Measurement
[3] Ingestion of test food A (number of intakes: 1 time)
[4] Washout (2 weeks)
[5] Designated food intake (number of intakes: 8 times)
[6] Animal Urine Measurement
[7] Ingestion of placebo food (number of intakes: 1 time)
[8] Washout (2 weeks)
[9] Designated food intake (number of intakes: 8 times)
[10] Animal Urine Measurement
[11] Ingestion of test food B (number of intakes: 1 time)
Interventions/Control_3
[1] Designated food intake (number of intakes: 8 times)
[2] Animal Urine Measurement
[3] Ingestion of placebo food (number of intakes: 1 time)
[4] Washout (2 weeks)
[5] Designated food intake (number of intakes: 8 times)
[6] Animal Urine Measurement
[7] Ingestion of test food B (number of ingestions: 1 time)
[8] Washout (2 weeks)
[9] Designated food intake (number of intakes: 8 times)
[10] Animal Urine Measurement
[11] Ingestion of test food A (number of ingestions: 1 time)
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[1] Healthy Glico Group Employees
[2] Those with high fasting blood glucose levels (110~125mg/dL will be prioritized for screening tests)
[3] Those who have voluntarily agreed to participate in the trial in writing
Key exclusion criteria
[1] Those with a fasting blood glucose level of 126 mg/dL or higher at the time of screening test
[2] Those who are continuously consuming health foods, quasi-drugs, or pharmaceuticals that advocate or cooperate with the same or related effects as those examined in this study
[3] Those who have started using health foods within the past 4 weeks
[4] Those who work night shifts and day and night shifts
[5] A person who is undergoing treatment (hormone replacement therapy, drug therapy, exercise therapy, diet, etc.) at a medical institution for the treatment or prevention of a disease at the time of obtaining consent, or a person who is judged to be in need of treatment
[6] Those who have a history of glucose metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system, or psychiatric disorder
[7] Those who have a history of alcohol or drug dependence
[8] Those who are at risk of developing allergies to foods, especially those who are at risk of developing allergies to the ginger family
[9] Those who have experienced poor mood or deterioration of physical condition due to blood collection in the past, or those who have been told that it is difficult to collect blood due to thin blood vessels
[10] Those who regularly use supplements or pharmaceuticals, or those who are unable to refrain from using them
[11] Persons with severe anemia symptoms
[12] Those who are pregnant or breastfeeding at the time of obtaining consent, or who wish to become pregnant during the study period
[13] Those who plan to participate in other human studies (e.g., human trials using foods, pharmaceuticals, quasi-drugs, medical devices, etc.) during the scheduled period of this study
[14] A person who is judged by the study investigator or the study principal to be unfit to participate in the study
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medicial Corporation Kenshokai
Division name
Fukushima Healthcare Center
Zip code
553-0004
Address
Tamagawa 2-12-16, Fukushima-ku, Osaka-shi, Osaka, Japan
TEL
06-6882-1130
drc_shokuhin@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Naganuma |
Organization
DRC Co., Ltd
Division name
Product Testing Department
Zip code
530-0044
Address
No.9 Tabuchi Bldg. 3F, 2-10-31, Higashi-Temma, Kita-ku, Osaka, Japan
TEL
06-6882-1130
Homepage URL
naganuma@drc-web.co.jp
Sponsor or person
Institute
DRC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
2F, Shiratori Building, 1-2, Shinjuku 2-chome, Shinjuku-ku, Tokyo, Japan
Tel
03-4405-1899
ethics_board@drc-web.co.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
DRCクリニック(大阪府)
Other administrative information
Date of disclosure of the study information
| 2025 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065326
