UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055574 |
|---|---|
| Receipt number | R000063502 |
| Scientific Title | A study of the effect of probiotics on the intestinal environment as a result of protein supplementation -A Randomized, Double-Blind, Placebo-Controlled trial |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2025/09/29 09:34:35 |
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Basic information
Public title
A study of the effect of probiotics on the intestinal environment as a result of protein supplementation
-A Randomized, Double-Blind, Placebo-Controlled trial
Acronym
A study of the effect of probiotics on the intestinal environment as a result of protein supplementation
-A Randomized, Double-Blind, Placebo-Controlled trial
Scientific Title
A study of the effect of probiotics on the intestinal environment as a result of protein supplementation
-A Randomized, Double-Blind, Placebo-Controlled trial
Scientific Title:Acronym
A study of the effect of probiotics on the intestinal environment as a result of protein supplementation
-A Randomized, Double-Blind, Placebo-Controlled trial
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of probiotics on the effects of protein supplement intake on intestinal microbiome, metabolites in stool, etc. in healthy adult subjects.
Basic objectives2
Others
Basic objectives -Others
Exploratory investigation of the effects of probiotics on the effects of protein supplement intake on the intestinal environment and other factors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intestinal environment
Key secondary outcomes
fecal frequency, fecal characteristics, dietary survey, physical examination, skin gas, condition assessment, gastrointestinal symptoms
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
Test food intake for 4 weeks
Interventions/Control_2
Placebo food intake 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1.Healthy male who are age of at least 18 years of age
2.Subjects who continue or increase the intake of protein supplements to the specified dosage during the study food intake period.
Key exclusion criteria
1.Subjects who have a current or past history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease.
2.Subjects who regularly use medicine that affect the gut microbiota such as Intestinal regulators, laxatives, etc.
3.Subjects who have lactose intolerance.
4.Subjects who are unable to discontinue foods or supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, etc. during the study period.
5.Subjects whose daily protein intake is 3.0 g/kg body weight/day or more.
6.Subjects who have drug allergy, food allergy or medical history.
7.Individuals who participated in other clinical trials in the past 1 month or who are going to participate in other trials in this study period.
8.Subjects considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1, Hirakagakuendai, Inzai, Chiba, Japan
TEL
0476-98-1001
machidas@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1, Hirakagakuendai, Inzai, Chiba, Japan
TEL
0476-98-1001
Homepage URL
machidas@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Ethics committee in Juntendo University Graduate School of Health and Sports Science
Address
1-1, Hirakagakuendai, Innzai, Chiba, Japan
Tel
0476-98-1001
sc-rinri@juntendo.ac.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
順天堂大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 30 | 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
60
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
| 2024 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 07 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063502
