UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044037 |
|---|---|
| Receipt number | R000050284 |
| Scientific Title | Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition. -A placebo-controlled, randomized, double-blind clinical trial- |
| Date of disclosure of the study information | 2021/05/07 |
| Last modified on | 2022/03/16 14:17:33 |
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Basic information
Public title
Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition. -A placebo-controlled, randomized, double-blind clinical trial-
Acronym
Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition.
Scientific Title
Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition. -A placebo-controlled, randomized, double-blind clinical trial-
Scientific Title:Acronym
Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to investigate the effect of continuous consumption of the test food on immunological markers, fecal odors, and fecal condition on healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immunological markers
Questionnaire for fecal conditions
Questionnaire for physical conditions
fecal condition markers (including fecal odors)
gut microbiota
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
Take 1 packet of the test food before sleeping once per day.
Interventions/Control_2
Take 1 packet of the placebo food before sleeping once per day.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Age between 40 and 70 years at the time of informed consent
2.Japanese male or female
3.Those who have contracted an upper respiratory infection every year.
4.Those who are able to input electronic diary with smartphone / PC
5.Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.
Key exclusion criteria
1.Those who has been currently visiting a hospital or treated with any drug or herbal remedy (however, dosing as needed is allowed) for any disease.
2.On diet / exercise therapy under the guidance of a doctor
3.Have a current or history of serious illness
4.Those who have allergic dermatitis, (perennial/seasonal) allergic rhinitis, bronchial asthma, and chronic bronchitis.
5.Those who have currently been taking drugs, quasi-drug products, and foods or supplements which have health claims. However, those who can discontinue taking these materials during the trial period after obtaining informed consent will be allowed to join the trial.
6.Those who have a current or previous history of drug and/or food allergies
7.Take lactic acid bacteria drinks, yogurt or supplements containing lactic acid bacteria daily.
8.Excessive consumption of alcohol (alcohol equivalent 60g or more / day)
9.Planning to significantly change their lifestyle (diet, sleep, exercise, etc.) during the trial.
10.Those who are planning travels to foreign countries during the trial period.
11.Irregular diet, shift worker, night shift, irregular life rhythm
12.Those who are currently pregnant or breastfeeding or those who want to become pregnant during the test period.
13.Participation in another clinical trial within one month of enrollment into the trial, participating currently or planning to participate.
14.Those who were determined by the investigator to be unsuitable for participation in this clinical trial.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Okamori |
Organization
Nichinichi pharmaceutical Co., Ltd
Division name
Central Research Laboratory
Zip code
519-1413
Address
239-1 Tominaga, Iga-city, Mie 518-1417
TEL
0595-48-0201
lab@nichinichi-phar.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
h-kayama@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Nichinichi Pharmaceutical 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2021 | Year | 05 | 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
| 2021 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 26 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050284
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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