UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000045502 |
|---|---|
| Receipt number | R000051946 |
| Scientific Title | A study on the effect of single intake of the test food on blood sugar-related biological markers -a placebo-controlled, double-blind, four-period crossover trial- |
| Date of disclosure of the study information | 2022/10/08 |
| Last modified on | 2022/03/16 14:19:29 |
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Basic information
Public title
A study on the effect of single intake of the test food on blood sugar-related biological markers -a placebo-controlled, double-blind, four-period crossover trial-
Acronym
A study on the effect of single intake of the test food on blood sugar-related biological markers
Scientific Title
A study on the effect of single intake of the test food on blood sugar-related biological markers -a placebo-controlled, double-blind, four-period crossover trial-
Scientific Title:Acronym
A study on the effect of single intake of the test food on blood sugar-related biological markers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of a single intake of the test food on blood sugar-related biological markers (blood sugar and FGF-21) in healthy males aged between more than 20 to less than 60.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fibroblast growth factor-21 (FGF-21)
Key secondary outcomes
Blood glucose level
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take the placebo food (350 mL, room temperature) within 10 min in a sitting position with resting.
Interventions/Control_2
Take the test food A (350 mL, room temperature) within 10 min in a sitting position with resting.
Interventions/Control_3
Take the test food B (350 mL, room temperature) within 10 min in a sitting position with resting.
Interventions/Control_4
Take the test food C (350 mL, room temperature) within 10 min in a sitting position with resting.
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
Key inclusion criteria
1. Aged between over than 20 years old, and less than 60 years old.
2. Japanese males.
3. Body weight between 50 to 70 kg. (Also, BMI less than 25.0 kg/m^2)
4. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1. Individuals who currently have been taking any medication drugs or Chinese herbal medicines for medical treatments. (Single dose to be taken only once is approved.)
2. Individuals who have severe diseases or a history of severe diseases, such as cardiac-, hepatic-, kidney-, and digestive- diseases.
3. Individuals who are managed by medical doctors for diet therapy and exercise therapy.
4. Individuals who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims which affect blood sugar levels. (However, individuals who can discontinue taking these materials during the trial period after obtaining informed consent will be allowed to join the trial.)
5. Individuals who drink more than 60 g alcohol/day.
6. Individuals who live irregular life rhythms, such as work in shift, night shift, and marked irregular eating habits.
7. Individuals who joined other clinical trials from 1 month before obtaining informed consent in this trial, or those who have currently been joined other clinical trials. Also, those who are planning to join other clinical trials between 4 weeks after this trial.
8. Individuals who can't stop drinking one day before the experimental day.
9. Individuals who have drug allergies and food allergies.
10. Individuals who are unsuitable for this trial, that judged by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
HigashiKoganei Sakura Clinic
Division name
Hospital director
Zip code
184-0011
Address
4-37-26 Higashicho, Koganei-shi, Tokyo, Japan
TEL
042-382-3888
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
h-kayama@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2022 | Year | 10 | Month | 08 | 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
| 2021 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051946
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