UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048299 |
|---|---|
| Receipt number | R000055042 |
| Scientific Title | Evaluation of the effects of test food intake on the intestinal environment |
| Date of disclosure of the study information | 2023/07/07 |
| Last modified on | 2023/06/30 11:01:37 |
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Basic information
Public title
Evaluation of the effects of test food intake on the intestinal environment
Acronym
Evaluation of the effects of test food intake on the intestinal environment
Scientific Title
Evaluation of the effects of test food intake on the intestinal environment
Scientific Title:Acronym
Evaluation of the effects of test food intake on the intestinal environment
Region
| Japan |
Condition
Condition
Healthy adult male/female subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the test food intake on intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short-chain fatty acids content in fecal samples taken at the time of 24 weeks
Key secondary outcomes
- Intestinal microbiota
- Intestinal metabolites
- Defecation status (days of defecation, frequency of defecation, volume of stool, stool consistency, stool color, feeling of residual stool during defecation, abdominal pain during defecation, odor)
- Blood microRNA
- Clinical laboratory values
- Alteration in clinical laboratory values
- Adverse event/Side effect
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
Ingesting the test food by replacing the staple food (carbohydrates) with a piece of microwaved test food in either breakfast, lunch, or dinner.
Interventions/Control_2
Ingesting the placebo food by replacing the staple food (carbohydrates) with a piece of microwaved control food in either breakfast, lunch, or dinner.
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) Men and women aged between 20 and 64 at the time of obtaining consent
(2) Persons who can consume one serving of the test food per day
(3) Persons who can receive the test food once a week
(4) Those who defecate between three and five times a week
(5) Persons who have been fully informed about the test, understand its content and are able to give their written consent
Key exclusion criteria
(1) Persons who consume foods for specified health uses, functional foods, health foods, yoghurt or probiotic drinks at least three times a week, which may affect the test
(2) Persons who have taken, or plan to take during the study period, any medication that will affect the study one month prior to the pre-test
(3) Persons with a history of appendectomy
(4) Persons who have undergone surgery within six months from the time consent was obtained that may have affected the study
(5) Heavy alcohol drinkers
(6) Persons whose roommates are planning to participate in the same study
(7) Persons with extremely irregular eating habits
(8) Persons who had one or less meals per day at least once a week during the month prior to application for the trial
(9) Persons who plan to change their existing lifestyle, eating habits or living environment during the trial period
(10) Those currently participating in a clinical trial of another medicine or health food product and plan to participate in another clinical trial within 4 weeks of the completion of the trial, or after consent to participate in the trial
(11) Persons with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
(12) Pregnant, lactating or intending to become pregnant during the study period
(13) Persons with allergies to medicinal products or food (especially wheat, egg and milk)
(14-16) Subjects who donated their blood components and/or whole blood prior to the pre-inspection as follows;
- any subjects: 200 mL within a month
- males: 400 mL within the last 3 months
- females: 400 mL within the last 4 months
(17-18) Subjects whose collected blood volume within the last 12 months would reach to following criteria after adding the blood collection in this study;
- males: 1,200 mL
- females: 800 mL
(19) Persons who are deemed by the study investigator or sub-investigator to be unsuitable to participate in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Division
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
+81-3-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nissin Flour Milling 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
+81-3-6225-9005
IRB@cpcc.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
| 2023 | Year | 07 | Month | 07 | 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 | 06 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 26 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055042
