UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046190 |
|---|---|
| Receipt number | R000052682 |
| Scientific Title | An exploratory study on the effect of continuous intake of test foods on the immune system. -a randomized, placebo-controlled, double-blind, parallel-group comparison trial- |
| Date of disclosure of the study information | 2022/12/27 |
| Last modified on | 2025/02/14 14:12:44 |
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Basic information
Public title
An exploratory study on the effect of continuous intake of test foods on the immune system. -a randomized, placebo-controlled, double-blind, parallel-group comparison trial-
Acronym
An exploratory study on the effect of continuous intake of test foods on the immune system.
Scientific Title
An exploratory study on the effect of continuous intake of test foods on the immune system. -a randomized, placebo-controlled, double-blind, parallel-group comparison trial-
Scientific Title:Acronym
An exploratory study on the effect of continuous intake of test foods on the immune system.
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 intake of test foods for 12 weeks on immune function and physical condition in healthy males and females aged between 50 and less than 65 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune function-related biomarkers
Physical condition questionnaire
QoL questionnaire
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 two capsules of the placebo food after breakfast once every day.
Interventions/Control_2
Take two capsules of the test food after breakfast once every 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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged between 50 and less than 65 years old.
2. Japanese males and females.
3. Individuals who contract the common cold between winter and spring every year.
4. BMI between 17.5 kg/m^2 and less than 30.0 kg/m^2.
5. Individuals who can use smartphones or PCs to input an electronic diary.
6. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1. Individuals who have mouth dryness, or hypersalivation.
2. Individuals who are currently undergoing treatment for any disease with medical drugs or traditional Chinese medicines. However, medications used as needed will be allowed to join the trial.
3. Individuals who are managed by medical doctors for diet therapy and exercise therapy.
4. Individuals who have severe diseases or a history of severe diseases.
5. Individuals who have allergic dermatitis, allergic rhinitis, bronchial asthma, or chronic bronchitis.
6. Individuals who have been taking yogurts or beverages, which include Lactic acid bacteria and/or Bifidobacterium.
7. Individuals who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims.
8. Individuals who have a drug allergy, or a food allergy.
9. Individuals who work in shift, night shift, and marked irregular work in shift.
10. Individuals who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the trial period.
11. Individuals who drink more than 60 g alcohol/day.
12. Individuals who have been vaccinated to protect against infectious disease one month before the screening period. Also, individuals who are planning vaccination during the trial period.
13. Individuals who are planning travel to foreign countries during the trial period.
14. Individuals who joined other clinical trials from 1 month before obtaining informed consent in this trial, or individuals who have currently been joined other clinical trials. Also, individuals who are planning to join other clinical trials.
15. Individuals who donated blood more than 200 mL within one month before, or more than 400 mL within three months before the screening period.
16. Individuals who cannot discontinue taking any alcoholic drinks two days before the date of visit.
17. Individuals who are unsuitable for this trial, that judged by the principal investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Norihisa |
| Middle name | |
| Last name | Nishida |
Organization
Kobelco Eco-Solutions Co.,Ltd.
Division name
Algae Business Promotion Department
Zip code
651-0072
Address
1-4-78, Wakinohama-cho, Chuo-ku, Kobe-shi, Hyogo, Japan
TEL
078-232-8384
nishida.norihisa@kobelco.com
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co, Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 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
Kobelco Eco-Solutions 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
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
| 2022 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1756464623004048
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1756464623004048
Number of participants that the trial has enrolled
24
Results
The test food group had fewer days with some cold-like symptoms than the placebo group, and higher levels of surface molecules that indicate the active state of monocytes, CD4+ naive T cells, CD8+ naive T cells.
The original paper reporting the results is as follows:
High-parameter immune profiling and subjective health assessment of the immunomodulatory effects of paramylon-rich Euglena gracilis EOD-1: A randomized, double-blind, placebo-controlled, parallel-group study, J.Funct.Foods, 109, 105804 (2023)
Results date posted
| 2025 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 23 | Day |
Baseline Characteristics
Healthy males and females whose age of 50 years or more and less than 65 years
Participant flow
Completed(n=23)
Analyzed(n=22)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
Immune function-related biomarkers
Physical condition questionnaire
QoL questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 22 | 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 | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052682
