UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057599 |
|---|---|
| Receipt number | R000065812 |
| Scientific Title | Test of suppression of postprandial blood glucose elevation by food ingestion |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/12 17:16:49 |
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Basic information
Public title
Test of suppression of postprandial blood glucose elevation by food ingestion
Acronym
Test of suppression of postprandial blood glucose elevation by food ingestion
Scientific Title
Test of suppression of postprandial blood glucose elevation by food ingestion
Scientific Title:Acronym
Test of suppression of postprandial blood glucose elevation by food ingestion
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the inhibitory effect of test foods on postprandial blood glucose elevation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in postprandial blood glucose levels
Key secondary outcomes
Changes in postprandial insulin
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
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single intake of bitter melon and foods containing corosolic acid
Interventions/Control_2
Single intake of placebo foods containing corosolic acid
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Male and female subjects aged 20 to 64 years
(2) Normal to slightly elevated fasting blood glucose level (125 mg/dL or less) at baseline
(3) Subjects who give written voluntary consent to participate in the study
Key exclusion criteria
(1) Those who have been diagnosed with diabetes and are currently undergoing treatment
(2) Those who are currently taking medication for diabetes or high blood pressure
(3) Those who are currently taking the test food or health food
(4) Those who regularly take supplements related to cholesterol, blood pressure, blood lipids, or blood sugar levels
(5) Those with serious diseases or mental disorders of the following systems: sugar metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system. Those with a history of such diseases or disorders
(6) Those who have been found to have abnormal clinical test values and are judged to have problems participating in the study
(7) Those with diseases that are currently being treated or who have a history of serious diseases that required medication treatment
(8) Those who may develop allergies in relation to the study
(9) Those who are judged to be unsuitable as subjects based on the results of the lifestyle questionnaire
(10) Those who are participating in other clinical research at the start of this study
(11) Those who are pregnant or plan to become pregnant or breastfeed during the study period
(12) Those who are judged to be unsuitable for participation in the study by the principal investigator (or the person in charge of conducting the study)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Takeda |
Organization
Kansai University of Welfare Sciences
Division name
Department of Nutritional Sciences for Welll-being, Faculty of Health Science for Welfare
Zip code
582-0026
Address
Asahigaoka 3-11-1, Kashiwara, Osaka
TEL
072-978-0088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Shigefumi |
| Middle name | |
| Last name | Nibun |
Organization
EAS inc.
Division name
Clinical Trial Session
Zip code
236-0028
Address
Susaki-Cho1-10-2F, Kanazawa-ku, Yokohama city, Kanagawa
TEL
070-5415-3051
Homepage URL
info@eas-ct.jp
Sponsor or person
Institute
Lifix Corporation
Institute
Department
Personal name
Funding Source
Organization
Lifix Corporation
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
KOBUNA ORTHOPEDIC SURGERY
Address
311-2, Gokan-machi, Maebashi, Gunma
Tel
027-261-7600
sagawa@mc-connect.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | 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 | 04 | Month | 12 | Day |
Last modified on
| 2025 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065812
