UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051798 |
|---|---|
| Receipt number | R000059112 |
| Scientific Title | A Study of the effects of a test-food on gut microenvironment Placebo-controlled, randomized, double-blind crossover |
| Date of disclosure of the study information | 2024/08/02 |
| Last modified on | 2024/06/21 13:52:17 |
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Basic information
Public title
A Study of the effects of a test-food on gut microenvironment
Placebo-controlled, randomized, double-blind crossover
Acronym
A Study of the effects of a test-food on gut microenvironment
Placebo-controlled, randomized, double-blind crossover
Scientific Title
A Study of the effects of a test-food on gut microenvironment
Placebo-controlled, randomized, double-blind crossover
Scientific Title:Acronym
A Study of the effects of a test-food on gut microenvironment
Placebo-controlled, randomized, double-blind crossover
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to validate some kind of effect by the test-food intakes for four weeks on gut microenvironment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal flora (next generation-targeted amplicon sequencing analysis)
Key secondary outcomes
1. Defecation status; the number of days, frequency, quantity, property, color, fecal odor, feeling of incomplete evacuation, abdominal pain
2. In stool; short chain fatty acids, organic acids, ammonia, spoiled products, pH and water
3. In saliva; cortisol, cortisol corrected by protein, alpha-amylase, and alpha-amylase corrected by protein
4. Constipation assessment scale mid term
5. Visual Analog Scale; stress, fatigue, the feeling at waking up this morning, concentration
6. Clinical test value
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Consumption of the test food, one a day for 4 weeks.
Interventions/Control_2
Consumption of the placebo food, one a day for 4 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)Healthy male/female subjects ranging in age from 20 to 64, at informed consent.
(2) Subjects who defecate less than five times a week.
(3) Subjects who can take two meal of the test food per day.
(4) Subjects who can receive and keep the test foods once or twice a week.
(5) Subjects who can give informed consent, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who have an experience of living with serious disease.
2. Subjects who have chronic diseases.
3. Patients with gastrointestinal diseases that affect digestion and absorption or defecation.
4. Subjects who have an experience of drug dependence or alcohol dependence.
5. Subjects who plan to take medicines that affect the intestinal environment that affect bowel movements from 1 month.
6. Subjects who habitually consume foods containing a large amount of dietary fiber.
7. Subjects who are taking antibiotics or antibacterial agents.
8. Subjects who consume health foods that may improve constipation.
9. Subjects who have reported allergies to food or medicines.
10. Subjects who consistently drink more than the appropriate amount of alcohol.
11. Subjects who smoke excessively (more than 21 cigarettes/day).
12. Subjects with a BMI of 30.0 or more.
13. Pregnant
14. Subjects who participate in research involving the intake of other foods or using drugs.
15. Subjects who plan to participate in the research with cohabitants.
16. Subjects who plan to change their lifestyle, diet, or living environment.
17. Subjects with irregular eating habits.
18. Subjects who had less than one meal per day.
19. Subjects who plan to receive vaccines during the study period.
20. Subjects who have collected more than 200 mL of blood within 1 month or more than 400 mL within 3 months prior to the date of obtaining consent.
21. Subjects who are on a carbohydrate restriction or diet.
22. Subjects who are judged to be inappropriate as research subjects by the principal investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13-4 Nihonbashi Kodenmacho Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
7F Shibaura-Omodaka Building, 1-9-7 Shibaura, Minato-ku, Tokyo 105-0023, Japan
TEL
03-3452-7733
Homepage URL
Eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Nisshin Seifun Group 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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 | 08 | Month | 02 | 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
24
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
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059112
