UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054908 |
|---|---|
| Receipt number | R000062729 |
| Scientific Title | A study of growth of Akkermansia on Forsythia leaf extract containing arctigenin |
| Date of disclosure of the study information | 2024/07/08 |
| Last modified on | 2025/02/14 16:35:09 |
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Basic information
Public title
A study of growth of Akkermansia on Forsythia leaf extract containing arctigenin
Acronym
A study to test the influence of plant extract materials on intestinal bacteria
Scientific Title
A study of growth of Akkermansia on Forsythia leaf extract containing arctigenin
Scientific Title:Acronym
A study to test the influence of plant extract materials on intestinal bacteria
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of ingestion of arctigenin extracted from Forsythia leaves on the occupancy rate of Akermansia in healthy adults carrying Akkermansia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relative occupancy of Akkermansia after 4 and 8 week of ingestion
Key secondary outcomes
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
Intake of test food for 8 weeks
Interventions/Control_2
Intake of placebo 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Subjects aged 20 to 65 at the time of obtaining consent
2.Subjects who carry Akkermansia
3.Subjects who have not taken any foods for specified health uses, functional foods, dietary supplements, that may affect defecation, or who can maintain the same type and frequency of intake of these products they have been taking up until that point during the study period
4.Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1.Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2.Subjects receiving treatment for a gastrointestinal disease currently or those who have had gastrointestinal surgery
3.Subjects who are suffering from or have a history of a disease that may affect defecation
4.Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for microbiome such as intestinal regulator
5.Subjects who have used antibiotics within the past month
6.Subjects with irregular lifestyles due to night shifts
7.Female subjects who are pregnant or lactating, or intending to become pregnant during the study
8.Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study
9. Subjects deemed unsuitable by the investigator
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Shimpei |
| Middle name | |
| Last name | Watanabe |
Organization
Kracie, Ltd.
Division name
Life Sciences Research Department Well-being Research Center R&D Headquarters
Zip code
240-0005
Address
134 Kobe-cho, Hodogaya-ku, Yokohama
TEL
045-338-3755
shimpei.watanabe@kracie.co.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | K |
| Last name | Takeda |
Organization
Cykinso, Inc.
Division name
Medical & Clinical Division
Zip code
151-0053
Address
1-36-1 Yoyogi, Shibuya-ku, Tokyo
TEL
03-5309-2522
Homepage URL
mykinsoresearch_mq01@cykinso.co.jp
Sponsor or person
Institute
Kracie, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kracie, 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
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
| 2024 | Year | 07 | 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
54
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 | 06 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 11 | Month | 14 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062729
