UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062480 |
|---|---|
| Receipt number | R000071510 |
| Scientific Title | Study on the Effects of Continuous Intake of Foods Containing Fermented Panax ginseng Extract on Gut Microbiota and Health |
| Date of disclosure of the study information | 2026/08/05 |
| Last modified on | 2026/08/05 16:33:24 |
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Basic information
Public title
Study on the Effects of Continuous Intake of Foods Containing Fermented Panax ginseng Extract on Gut Microbiota and Health
Acronym
Study on the Effects of Continuous Intake of Foods Containing Fermented Panax ginseng Extract
Scientific Title
Study on the Effects of Continuous Intake of Foods Containing Fermented Panax ginseng Extract on Gut Microbiota and Health
Scientific Title:Acronym
Study on the Effects of Continuous Intake of Foods Containing Fermented Panax ginseng Extract
Region
| Japan |
Condition
Condition
Healthy adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a food containing fermented red ginseng extract on the gut microbiota in healthy adult men, compared to a placebo food.
Basic objectives2
Others
Basic objectives -Others
-To examine the relationship between changes in blood test parameters and gut microbiota fluctuations.
-To examine the relationship between changes in lifestyle/physical condition questionnaires (subjective symptoms, etc.) and gut microbiota fluctuations.
-To confirm adverse events associated with the intake of the test substance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in gut microbiota from baseline (week 0) to week 8, including variations in diversity (Shannon index, Bray-Curtis dissimilarity, etc.), relative abundance of each bacterial species/genus, and compositional changes in functional genes (pathways).
Key secondary outcomes
- Changes in blood test parameters (testosterone-related hormones, antioxidant/anti-inflammatory markers, lipid metabolism items, etc.).
- Changes in subjective symptoms and QOL scores (lifestyle, AIS, IPAQ, AMS scores) from baseline to 8 weeks post-intake.
- Correlation between gut microbiota fluctuations and changes in blood test items and questionnaire scores.
- Incidence of adverse events.
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Fermented red ginseng extract-containing food group: Oral intake of fermented red ginseng extract-containing food (10 g/packet), 2 packets/day for 8 weeks.
Interventions/Control_2
Placebo group: Oral intake of placebo food (without fermented red ginseng extract, 10 g/packet), 2 packets/day for 8 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
| 35 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Men aged 35 to 59 years, with no current disease under treatment and in good health.
2. Those who have provided written informed consent to participate in this study.
3. Those who can continuously visit the clinic during the study period.
Key exclusion criteria
1. Those with severe systemic diseases (heart disease, liver disease, kidney disease, inflammatory bowel disease, diabetes, etc.).
2. Those with a history of or currently undergoing treatment for malignant tumors.
3. Those with a history of or currently undergoing treatment for autoimmune diseases.
4. Those using immunosuppressants or steroid drugs.
5. Those who have taken medications affecting the gut microbiota (antibiotics, proton pump inhibitors (PPIs), potassium-competitive acid blockers (PCABs), and probiotics) within the past month.
6. Those who have consumed drugs or foods containing ginseng within the past month.
7. Those with a known history of allergy to ginseng.
8. Those who dislike the flavor of foods containing ginseng and cannot consume them continuously.
9. Those who have difficulty making decisions about study participation due to mental illness.
10. Others deemed inappropriate by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mark |
| Middle name | |
| Last name | Soshi |
Organization
to clinic shibuya
Division name
Director
Zip code
1506207
Address
Shibuya Sakurastage 7F, 1-4, Sakuragaoka-cho, Shibuya-ku, Tokyo
TEL
0364552976
mark.soshi@toclinic.jp
Public contact
Name of contact person
| 1st name | Rakan |
| Middle name | |
| Last name | Matsui |
Organization
KINS Co., Ltd.
Division name
Drug Discovery and R&D Department, Business Development Division
Zip code
1360082
Address
Shin-Kiba Center Building, Shin-Kiba Life Science Hub 7F 7007, 1-18-6, Shin-Kiba, Koto-ku, Tokyo
TEL
08047843782
Homepage URL
matsui_rakan@yourkins.com
Sponsor or person
Institute
to clinic shibuya
Institute
Department
Personal name
Funding Source
Organization
KINS 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
Shiba Palace Clinic Ethics Review Committee
Address
Daiwa A Hamamatsucho Bldg. 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
05033909275
y_huzita@mail.souken-r.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
| 2026 | Year | 08 | Month | 05 | 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
107
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
| 2026 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071510
