UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052681 |
|---|---|
| Receipt number | R000060010 |
| Scientific Title | Effect of Test Food to Suppress the Increase in Postprandial Blood Glucose Level |
| Date of disclosure of the study information | 2023/11/06 |
| Last modified on | 2024/04/26 10:24:00 |
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Basic information
Public title
Effect of Test Food to Suppress the Increase in Postprandial Blood Glucose Level
Acronym
Effect of Test Food to Suppress the Increase in Postprandial Blood Glucose Level
Scientific Title
Effect of Test Food to Suppress the Increase in Postprandial Blood Glucose Level
Scientific Title:Acronym
Effect of Test Food to Suppress the Increase in Postprandial Blood Glucose Level
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine an effect of test food to suppress the increase in postprandial blood glucose level.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level (GLU) due to loading food intake (before loading, 30, 60, 90, and 120 minutes after loading)
(Observation period I and II)
Key secondary outcomes
*Secondary indexes
1) Insulin (IRI) due to loading food intake (before loading, 30, 60, 90, and 120 minutes after loading) (1)
2) HOMA-IR, HOMA-beta (1)
*Safety
1) Blood pressure, pulsation (1)
2) Weight, body fat percentage, BMI (1)
3) Doctor's questions (1)
4) Subject's diary (2)
(1): Observation period I and II
(2): From Observation Period I to the day before the Observation Period II
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
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
[1] Intake of test food/loading food (1 time/1 packet).
[2] Observation.
[3] Washout (over 6days)
[4] Intake of placebo food/loading food (1 time/1 packet).
[5] Observation.
Interventions/Control_2
[1] Intake of placebo food/loading food (1 time/1 packet).
[2] Observation.
[3] Washout (over 6days)
[4] Intake of test food/loading food (1 time/1 packet).
[5] Observation.
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) Japanese males and females aged 20-59 years.
2) Individuals who are healthy and have no chronic physical disease.
3) Individuals whose written informed consent has been obtained.
4) Individuals who can come to the designated venue for this study and be inspected.
5) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1)Individuals using medical products.
2)Individuals who are patient or have a history of glucose intolerance, psychiatric disease, sleep disorder, high blood pressure, diabetes, and hyperlipidemia.
3)Individuals whose fasting blood glucose is over 126mg/dL or HbA1c (NGSP) is over 6.5%.
4)Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
5)Individuals who are a patient or have a history of or endocrine disease.
6)Individuals who used a drug to treat a disease in the past 1 month.
7)Individuals whose BMI is over 30 kg/m2.
8)Individuals who are sensitive to the test food.
9)Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
10)Individuals who experienced unpleasant feeling during blood drawing.
11)Individuals who currently or within the past 3 months have a habit of continuously consuming foods with functional claims or health foods that claim to be related to glucose metabolism, or who plan to consume them during the test period.
12) Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent).
13)Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
14)Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
15)Individuals who engage in a night work.
16)Individuals who are or are possibly, or are lactating.
17)Females who menstruate on the day of the test and become anemic or feel unwell during the menstrual period.
18)Individuals who have difficulty in intaking the entire load food and test food (including preference).
19)Individuals who participated in other clinical studies in the past 3 months.
20)Individuals who are or whose family is engaged in functional foods or cosmetics.
21)Individuals judged inappropriate for the study by the principal.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
Riken Vitamin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Riken Vitamin 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
| 2023 | Year | 11 | Month | 06 | 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
| 2023 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060010
