UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044768 |
|---|---|
| Receipt number | R000051132 |
| Scientific Title | A study on the effect of the test food on immunological functions on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial- |
| Date of disclosure of the study information | 2021/11/11 |
| Last modified on | 2024/05/17 12:04:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the effect of the test food on immunological functions on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial-
Acronym
A study on the effect of the test food on immunological functions on healthy adults
Scientific Title
A study on the effect of the test food on immunological functions on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial-
Scientific Title:Acronym
A study on the effect of the test food on immunological functions on healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of continuous consumption of the test food for 8 weeks on systemic or local physical condition, and immune markers in healthy men and women aged between 30 to 70 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A subjective questionnaire for physical condition
Key secondary outcomes
Immune markers (TNFa, IFNg, IL6, IL4 and IL1b levels in blood, and cytotoxic activity of NK cells)
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 2 tablets the test food once a day with water or warm water after breakfast.
Interventions/Control_2
Take 2 tablets a placebo food once a day with water or warm water after breakfast.
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged between 30 and 70 years.
2. Japanese male or female.
3. Those who are susceptible to upper respiratory disease.
4. Those who can use smartphones or PCs to input an electronic diary.
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 are currently undergoing treatment for any disease. Also, those who receive medical treatments from medical doctors via drugs or traditional Chinese medicines.
2. Those who receive diet or exercise therapies by doctors.
3. Those who have severe diseases or history of severe diseases.
4. Those who have allergic dermatitis, 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 currently been taking yogurts or beverages, which include Lactobacillus and/or Bifidobacterium for being healthy. However, those who can discontinue taking these foods during the trial period after obtaining informed consent will be allowed to join the trial.
7. Those who received the vaccination against SARS-CoV2 after May 2021. Also, those who receive the vaccination during the trial period.
8. Those who have a drug allergy or a food allergy.
9. Those who work on the night shift and the shiftwork.
10. Heavy drinkers who drink over 60 g alcohol/day.
11. Those who have a smoking habit (over 21 cigarettes/day).
12. Those who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the trial period.
13. Those who are currently pregnant or breastfeeding, or those who are planning to pregnant during the trial period.
14. Those who are planning travels to foreign countries during the trial period.
15. Those who joined other clinical trials from 1 month before obtaining informed consent in this trial, or those who have currently been joined other clinical trials. Also, those who are planning to join other clinical trials.
16. Those who are unsuitable for this trial that judged by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Yamada |
Organization
LSI sapporo clinic
Division name
Director
Zip code
065-0013
Address
1-2-50 Kita 13 Jo higashi, Higashi-ku, Sapporo
TEL
0120-151-866
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
DENSO Corporation
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
jimukyoku@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 | 11 | Month | 11 | 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 | 06 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 11 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051132
