UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054248 |
|---|---|
| Receipt number | R000061940 |
| Scientific Title | Examination of changes in host metabolic indices and intestinal microflora due to consumption of test foods |
| Date of disclosure of the study information | 2025/12/13 |
| Last modified on | 2024/06/17 15:58:42 |
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Basic information
Public title
A study to evaluate the effect of test food on host metabolic indices and intestinal microflora
Acronym
A study to evaluate the effect of test food on host metabolic indices and intestinal microflora
Scientific Title
Examination of changes in host metabolic indices and intestinal microflora due to consumption of test foods
Scientific Title:Acronym
Examination of changes in host metabolic indices and intestinal microflora due to consumption of test foods
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine changes in metabolic indices and intestinal microflora in healthy adult male subjects during consumption of the test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area (CT scan)
Key secondary outcomes
Resting energy expenditure
Fecal amount of Bifidobacterium
Concentrations of acetic acid in feces and blood
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food three times a day for 12 weeks.
Interventions/Control_2
Consumption of the placebo food three times a day for 12 weeks.
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy men more than 30 and below 59 years old at the time of obtaining consent to participate in the study.
2) Subjects who have given written consent (Consent to participate in MYCODE Research) to participate in MYCODE Research or who are registered members of Lsmile participant panel.
3) Subjects with a BMI equal to or greater than 25 but less than 30.
4) Subjects with a waist circumference of 85 cm or more.
5) Subjects who have received sufficient explanation regarding the purpose and content of this study, are capable of giving consent, volunteer for participation willingly with a thorough understanding, consent to participate in this study, and are able to come to the examination venue on the specified examination date to undergo the examination.
Key exclusion criteria
1) Subjects with previous and/or current medical history of disease in digestive system or of serious disease in heart, lung, kidney, liver and blood etc..
2) Using drugs related to obesity, dyslipidemia or glucose metabolism disorders, and those who have been diagnosed with familial diseases related to these disorders.
3) Suffering from autoimmune diseases.
4) Subjects with severe anemia.
5) Currently taking antibiotics or have taken antibiotics in the past 2 weeks.
6) Allergic to test food ingredients (soybeans) or to the ingredients of the meal distributed the day before blood collection.
7) Subjects with a history of drug or alcohol abuse.
8) Subjects with pacemakers or other medical electronic devices.
9) Subjects who have difficulty in undergoing CT scans due to claustrophobia, etc..
10) Subjects who regularly use Functional Foods and Foods for Specified Health Uses related to the evaluation indices of this study (body fat, triglyceride, visceral fat, and metabolic rate).
11) Currently participating in another clinical trial (excluding non-interventional observational studies) or planning to participate in another clinical trial (excluding non-interventional observational studies) during this study.
12) Subjects who are judged to be unsuitable for this study by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Sassa |
Organization
Allm Inc.
Division name
Medical and Pharma DX Department
Zip code
1500043
Address
16F Shibuya Mark City West, 1-12-1 Dogenzaka, Shibuya-ku, Tokyo
TEL
03-4361-2650
IRB_dls@dena.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Matsuda |
Organization
Allm Inc.
Division name
Medical and Pharma DX Department
Zip code
1500043
Address
16F Shibuya Mark City West, 1-12-1 Dogenzaka, Shibuya-ku, Tokyo
TEL
03-4361-2650
Homepage URL
IRB_dls@dena.com
Sponsor or person
Institute
Allm Inc.
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha 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
The ethical committee of DeNA Life Science, Inc
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
Tel
03-6758-7200
IRB_dls@dena.com
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
| 2025 | Year | 12 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 14 | 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 | 04 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061940
