UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042417 |
|---|---|
| Receipt number | R000048419 |
| Scientific Title | The effect of continuous intake of test foods on health condition change |
| Date of disclosure of the study information | 2021/11/13 |
| Last modified on | 2025/01/16 18:13:46 |
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Basic information
Public title
The effect of continuous intake of test foods on health condition change
Acronym
The effect of continuous intake of test foods on health condition change
Scientific Title
The effect of continuous intake of test foods on health condition change
Scientific Title:Acronym
The effect of continuous intake of test foods on health condition change
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of continuous intake of test foods for 12 weeks on health condition change in male and female aged 20 to under 65 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaires to assess health condition
Key secondary outcomes
Indicators for upper respiratory tract infection, biomarkers
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take 2 tablets of test foods daily for 12 weeks.
Interventions/Control_2
Take 2 tablets of placebo foods daily for 12 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 20 to under 65 at the time of informed consent.
2. Male and Female
3. Those who suffered from upper respiratory tract infection during the winter season within the last two years
4. Those who can obtain written consent
Key exclusion criteria
1.Those who are currently under continuous treatment with drugs.
2. Those who have a positive reaction in the infectious disease test.
3. Those who are on a diet or exercise therapy under the supervision of a doctor.
4. Those who have a current or history of serious illness.
5. Those with atopic dermatitis, bronchial asthma, or chronic bronchitis
6. Those who have hay fever and allergic rhinitis (including seasonal and perennial)
7. Those who are currently using quasi-drugs, foods for specified health uses, health foods and supplements. Those who can quit during the test period after obtaining consent are allowed to participate.
8. Those who have been vaccinated against influenza vaccine after October 2020, or who are planning to be vaccinated during the test period
9. Those who have a past and current medical history of drug or food allergy.
10. Those who consume alcohol excessively (alcohol equivalent 60g or more / day)
11. Those who have excessive smoking habits (21 or more cigarettes / day)
12. Those who work in shifts, such as those who work night shifts
13. Those who are planning to travel abroad during the test period
14. Those who wish to become pregnant, breastfeeding, or during the test period
15. Those who have participated in other clinical trials within one month before obtaining consent, or those who plan to participate during the trial period
16. Those who are judged by the investigator or coordinator to be unsuitable for participating in this study
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Higashi Koganei Sakura Clinic
Division name
Chairman
Zip code
184-0011
Address
4-37-26,Higashicho,Koganei-shi,Tokyo,Japan
TEL
042-382-3081
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 Japan
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
Asahi Quality & Innovations, 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
| 2021 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.pieronline.jp/content/article/0386-3603/49080/1261
Publication of results
Published
Result
URL related to results and publications
https://www.pieronline.jp/content/article/0386-3603/49080/1261
Number of participants that the trial has enrolled
220
Results
In the study with subjective symptoms as the primary endpoint, local symptoms such as "runny nose", "stuffy nose", "cough", and "uncomfortable throat" were significantly relieved in the L-92 group compared to placebo group during the intake period. Similar to local symptoms, systemic symptoms such as "feverishness", "feel sick", "stress", and "fatigue" were significantly relieved in the L-92 group compared to placebo group.
Results date posted
| 2025 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study targeted healthy adult men and women aged 20 to 65 who were aware that they were susceptible to colds and had suffered from an upper respiratory tract infection within the last two years.
Participant flow
323 people were recruited, and 220 people started taking the test food. Four people dropped out for personal reasons, and 216 people completed the prescribed research schedule.
Of the 216 subjects, 2 subjects who violated the exclusion criteria (those who newly developed hay fever) were excluded, and the analysis was conducted on 214 subjects as the subjects for the efficacy analysis, including 107 subjects in the L-92 intake group and 107 subjects in the placebo intake group.
Adverse events
No incidents of harm caused by the test food were observed.
Outcome measures
Questionnaires to assess health condition
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048419
