UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046945 |
|---|---|
| Receipt number | R000053560 |
| Scientific Title | A randomized, double-blind, placebo-controlled study to evaluate the efficacy of the continuous intake of food containing quercetin glycoside on the SARS-CoV-2 vaccine efficacy in a healthy adult with a high body-mass index or elderly. |
| Date of disclosure of the study information | 2022/02/21 |
| Last modified on | 2026/04/16 14:50:54 |
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Basic information
Public title
A study to evaluate the efficacy of the continuous intake of food containing flavonoids (quercetin glycoside) on the SARS-CoV-2 vaccine efficacy in a healthy adult with a high body-mass index or elderly.
Acronym
A study to evaluate the efficacy of the intake of food containing flavonoids (quercetin glycoside) on the SARS-CoV-2 vaccine.
Scientific Title
A randomized, double-blind, placebo-controlled study to evaluate the efficacy of the continuous intake of food containing quercetin glycoside on the SARS-CoV-2 vaccine efficacy in a healthy adult with a high body-mass index or elderly.
Scientific Title:Acronym
A study to evaluate the efficacy of food intake containing quercetin glycoside on the SARS-CoV-2 vaccine efficacy.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The effect of continuous food intake containing quercetin for four weeks, before SARS-CoV-2 booster vaccination, on 1) the immune cells, or on 2) the anti-SARS-CoV-2 antibody and T-cell immunity will be evaluated by a randomized, double-blind, placebo-controlled study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Antibody titers against SARS-CoV-2 RBD at 2, 4, 12 weeks post-vaccination.
Key secondary outcomes
Antibody titers and neutralizing activity against SARS-CoV-2 RBD of variants of concern. Description of the daily health condition by participants.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Before SARS-CoV-2 booster vaccination, participants will take quercetin glycoside capsules twice a day for 4 weeks.
Interventions/Control_2
Before SARS-CoV-2 booster vaccination, participants will take placebo capsules twice a day 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects fully understand the significance, content, and purpose of this study and agree to participate with written informed consent (IC).
2. Japanese healthy males or females who are equal to or over 65 years of age at the time of obtaining IC, or who are equal to or over 20 years old with 23.0 kg/m2 BMI at the time of obtaining IC.
3. No medication for lifestyle disease at the time of obtaining IC.
4. Subjects who have received twice injections of SARS-CoV-2 vaccine, either Pfizer (BNT162b2) or Moderna (mRNA1273), then spent more than 7 months until 4 weeks post food intake.
5. Subjects who would like to have 3rd booster of SARS-CoV-2 vaccine of Moderna (mRNA1273).
6. Subjects who are willing to describe the self-health condition daily and capable of that.
Key exclusion criteria
1. Pacemaker or defibrillator users.
2. Subjects diagnosed as an unappropriated health condition by the corresponding clinician of the study.
3. Subjects who have severe cardiac or vascular disease, including thrombosis, blood, respiratory, hepatic, kidney, digestive, or psychiatric disorders, or have a history of such a condition.
4. Subjects who have an allergy such as systemic rash or a history of such symptoms.
5. Subjects who have seizures including febrile convulsion, Guillain-Barre syndrome, acute disseminated encephalomyelitis, or previous history.
6. Subjects who have been diagnosed with abnormal immunity by clinicians.
7. Subjects who have currently received medications, which potentially affect the evaluation of the immune responses, or who plan to have such drugs during this study.
8. Subjects who have previously anaphylactic reaction by food or drugs.
9. Subjects who have a history of anaphylactic reaction provoked by either the test food, the ingredients of the test food (quercetins or flavonoids), or potentially experience an anaphylactic reaction to them.
10. Subjects who plan to participate in other clinical studies until the end of this study from 4 weeks before the study.
11. Subjects who are pregnant, potentially pregnant, or lactating females.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | NISHIHIRA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
clinical-food@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institutes of Biomedical Innovation, Health and Nutrition
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 21 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 17 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 22 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053560
