UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048820 |
|---|---|
| Receipt number | R000055635 |
| Scientific Title | NR2022001 |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/02/26 19:06:21 |
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Basic information
Public title
Exploratory study on glucose metabolism by continuous intake of plant-extracted food
Acronym
Exploratory study on glucose metabolism by continuous intake of plant-extracted food
Scientific Title
NR2022001
Scientific Title:Acronym
NR2022001
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of truffle-mycelium-containing food on postprandial blood glucose level elevation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of blood glucose level
Key secondary outcomes
Fasting blood glucose level
Postprandial blood glucose level (30, 60, 90, 120 min)
maximum blood glucose level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of 2 packets of test food per day for 12 weeks
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 30 to 65 at the time of informed consent
2) Those with a BMI of 18.5 kg/m2 or more and less than 30.0 kg/m2
3) Subjects who have received a sufficient explanation of the purpose and content of the study and have signed a consent form before the start of the study
Key exclusion criteria
1) bowel disease (irritable bowel syndrome, Crohn's disease), liver disease, kidney disease, cardiovascular disease (brain and heart), diabetes, dyslipidemia, hypertension, epileptic seizures, sleep apnea, and other chronic diseases Those who are undergoing drug treatment due to past medical history or current medical history
2) Those who have a history of gastrointestinal surgery
3) Subjects who regularly use health foods that may affect inspection items
4) Subjects who cannot stop taking pharmaceuticals, quasi-drugs, and health foods from obtaining consent until the end of the study
5) heavy alcohol drinker
6) Those who have extremely irregular eating habits
7) Shift workers or late-night workers
8) a person who regularly uses some kind of drug
9) Subjects who plan to receive treatment during the intake period of the test food
10) Subjects with perennial atopic dermatitis or rhinitis
11) Those who have a history of anaphylactic shock in the past
12) Subjects judged inappropriate by the investigator and subinvestigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Rakan |
| Middle name | |
| Last name | Matsui |
Organization
NIKODERM RESEARCH INC.
Division name
Sales Division
Zip code
541-0052
Address
1-6-14, Azuchi-cho, Cyuou-ku, Osaka-City, Osaka
TEL
06-6125-3501
rmatsui@nikkolgroup.com
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Fujimoto |
Organization
Medical Corporation Kyoso-kai AMC Nishi-Umeda Clinic
Division name
Department of Clinical Research Center
Zip code
530-0001
Address
3F Maruito Nishiumeda Build. 3-3-45 Umeda, Kita-ku, Osaka
TEL
06-4797-5660
Homepage URL
fujimoto@amc-clinic.jp
Sponsor or person
Institute
NIKODERM RESEARCH INC.
Institute
Department
Personal name
Funding Source
Organization
NIKODERM RESEARCH INC.
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
Medical Corporation Kyoso-kai AMC Nishi-Umeda Clinic Ethics Review Committee
Address
Maruit Nishi-Umeda Building 3F, 3-3-45 Umeda, Kita-ku, Osaka-shi, Osaka, Japan
Tel
06-4797-5660
morikawa@amc-clinic.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 | 09 | 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
20
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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055635
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
