UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047224 |
|---|---|
| Receipt number | R000053859 |
| Scientific Title | A clinical study for evaluating of the effect of a supplement containing plant extract on the gut microbiome. -A Randomized, Double-blind, Placebo controlled, parallel-group Study- |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/09/27 15:18:14 |
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Basic information
Public title
A clinical study for evaluating of the effect of a supplement containing plant extract on the gut microbiome.
-A Randomized, Double-blind, Placebo controlled, parallel-group Study-
Acronym
A clinical study for evaluating of the effect of a supplement containing plant extract on the gut microbiome.
Scientific Title
A clinical study for evaluating of the effect of a supplement containing plant extract on the gut microbiome.
-A Randomized, Double-blind, Placebo controlled, parallel-group Study-
Scientific Title:Acronym
A clinical study for evaluating of the effect of a supplement containing plant extract on the gut microbiome.
Region
| Japan |
Condition
Condition
Healthy subjects with a tendency for constipation
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the supplement containing plant extract on the gut microbiome and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The analysis of the stool and defecation.
Key secondary outcomes
Subjective symptom
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
Continuous intake of the test food
Interventions/Control_2
Continuous intake of the placebo food
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese males and females between the ages of 40 and 64 years old at the time of obtaining consent to participate in the study.
2. Subjects with tendency of constipation.
3. Subjects available at every designated visit.
4. Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria
1. Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases.
2. Subjects with a surgical history of digestive system (except appendicectomy).
3. Subjects currently under treatment with chronic diseases.
4. Subjects with food allergies to the food ingredients used in the test.
5. Subjects who cannot refrain from ingesting lactic acid bacteria and dietary fiber-enriched foods that may affect on the intestinal functions from 1 week before ingestion of test food to the final stool collection day.
6. Subjects who wish to become pregnant during the study period (including the possibility of pregnant) or who are lactation or pregnant.
7. Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day).
8. Subjects who are participating in clinical trials or monitors other than this study or who are planning to participate during this study period.
9. Subjects who have donated or plan to donate 200 ml or more of blood separately from this study from 1 month before the primary screening to the end of the study.
10. Subjects who frequently skip food.
11. Subjects who work from 22:00 to 6:00 (shift worker, night- shift worker, etc).
12. Subject who cannot consume foods whose origin is not clearly indicated due to religious or other reasons.
13. Subjects judged as unsuitable for this study by the investigator for other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Ueno |
Organization
FUKUOKA KINEN PET KENSHIN CENTER
Division name
Internal medicine
Zip code
810-0054
Address
2-16-16, Imagawa, Chuo-ku, Fukuoka-shi, Fukuoka, Japan.
TEL
011-223-3130
takehara@csc-smo.co.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corporation Limited
Division name
Food Service Division
Zip code
060-0061
Address
4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
FUKUOKA KINEN PET KENSHIN CENTER
Institute
Department
Personal name
Funding Source
Organization
Fujifilm corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation Hokubukai beauty hill hospital ethics review committee
Address
No. 61, Maeda, Kiyota-ku, Sapporo, Hokkaido
Tel
011-882-0111
matsuda@ughp-cpc.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 | 12 | 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
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
| 2022 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2022 | Year | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053859
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