UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049491 |
|---|---|
| Receipt number | R000056356 |
| Scientific Title | Test of suppression of postprandial blood glucose elevation by food ingestion |
| Date of disclosure of the study information | 2023/10/31 |
| Last modified on | 2023/03/02 17:08:05 |
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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
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single intake of test foods containing bitter gourd, etc.
Interventions/Control_2
Single intake of placebo foods
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
| 60 | 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) Persons who are currently judged to have and treated diabetes mellitus (2) Persons who are currently receiving medication for diabetes mellitus or hypertension (3) Persons who are consuming foods or health foods containing ingredients of this experimental food (4) Persons who are regularly taking supplements related to cholesterol, blood pressure, blood lipids, blood sugar levels (5) Persons who have serious diseases related to sugar metabolism, lipid metabolism (6) Persons with serious diseases or mental disorders of liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system (6) Subjects with a history of abnormal laboratory values and judged to have problems in participating in the study (7) Subjects with a disease under treatment or a history of a serious disease requiring medication (8) Subjects at risk of developing allergies related to the study (9) Subjects who are not suitable as subjects based on the results of the Lifestyle Questionnaire. (10) Subjects who are participating in other clinical studies at the start of this study (11) Subjects who are pregnant or plan to become pregnant or breastfeeding during the study period (12) Subjects who are judged by the investigator (or the study administrator) to be unsuitable for study participation
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
Kashiwara-cuty
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
info@kobunaseikei.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
横浜みのるクリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 31 | 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
| 2022 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056356
