UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055406 |
|---|---|
| Receipt number | R000063302 |
| Scientific Title | Verification of the effect of consumption of jelly containing truffle extract on improving metabolic syndrome-related indicators. |
| Date of disclosure of the study information | 2024/09/04 |
| Last modified on | 2025/06/25 09:17:22 |
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Basic information
Public title
Verification of the effect of consumption of jelly containing truffle extract on improving metabolic syndrome-related indicators.
Acronym
Verification of the effect of consumption of jelly containing truffle extract on improving metabolic syndrome-related indicators.
Scientific Title
Verification of the effect of consumption of jelly containing truffle extract on improving metabolic syndrome-related indicators.
Scientific Title:Acronym
Verification of the effect of consumption of jelly containing truffle extract on improving metabolic syndrome-related indicators.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The test diet will be consumed for 10 weeks to evaluate the effect on improving metabolic syndrome-related indicators.
Changes in gut microbiota will also be evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body mass index (BMI), waist circumference
Key secondary outcomes
Intestinal microflora, hemoglobin A1c (HbA1c), low density lipoprotein (LDL) cholesterol, triglyceride
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 the test food per day for 10 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Persons with a BMI of 25kg/m2 or more.
(2)Those with a HbA1c of 6.0% or more, LDL-cholesterol of 140mg/dL or more, or triglycerides of 150 mg/dL or more as a result of a pre-test.
(3)Persons who are judged by the investigator to be able to safely participate in the study based on the results of pre-test.
Key exclusion criteria
(1)Persons under treatment for dyslipidemia, diabetes, or obesity.
(2)Those taking supplements for blood glucose and fat concerns for one month.
(3)Pregnant and lactating women.
(4)Persons who currently participating in another clinical trial or participated in one within the past 3 months.
(5)Other persons deemed ineligible by the study investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata Bio-Research Park, Inc
Division name
Advisor
Zip code
956-0841
Address
316-2, Higashijima, Akiha-ku, Niigata,956-0841, Japan
TEL
0250-25-1196
wataken@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Goto |
Organization
Niigata Bio Research Park, Inc
Division name
Business Promotion Department
Zip code
950-0841
Address
316-2 Higashijima,Akiha-ku, Niigata City, Niigata, Japan
TEL
0250-25-1196
Homepage URL
goto@nbrp.co.jp
Sponsor or person
Institute
Niigata Bio Research Park, Inc
Institute
Department
Personal name
Funding Source
Organization
Truffle Lab, 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
NBRC Research Ethics Review Committee
Address
316-2 Higashijima,Akiha-ku, Niigata City, Niigata, Japan
Tel
0250-25-1196
nbrp-food-navi@nbrp.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
| 2024 | Year | 09 | Month | 04 | 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
| 2024 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063302
