UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048641 |
|---|---|
| Receipt number | R000055003 |
| Scientific Title | Trial to confirm the usefulness of pyrroloquinoline quinone disodium salt (PQQ) ingestion |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2024/04/22 09:33:15 |
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Basic information
Public title
Trial to confirm the usefulness of pyrroloquinoline quinone disodium salt (PQQ) ingestion
Acronym
PQQ clinical trial
Scientific Title
Trial to confirm the usefulness of pyrroloquinoline quinone disodium salt (PQQ) ingestion
Scientific Title:Acronym
PQQ clinical trial
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects on muscle strength and physical function of a test food given to healthy men and women for 12 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower limb extensor strength
Key secondary outcomes
1)10m shuttle walking
2)6-minute walking test
3)Grip strength
4)10m walking test
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
Intake the test food (PQQ blended food) for 12 weeks
Interventions/Control_2
Intake the control food 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females between the ages of 20 and less than 75 at the time of obtaining consent to participate in the test
2)Healthy persons who are not currently being treated for any serious illness
3)Those who score 13 or more points on the ADL (Activities of Daily Living Test) questionnaire administered beforehand
4)Those who can visit the designated facility on the scheduled visit date
5)Those who fully understand the purpose and content of this test and have agreed in writing
Key exclusion criteria
1)Those who meet the diagnostic criteria for sarcopenia
2)Those who have a continuous exercise habit of at least 2 days per week
3)Those who have been attending the hospital for knee, back or other joint pain within 3 months
4)Those with a history of major surgery in the gastrointestinal tract area, such as gastrectomy, gastrointestinal suture, or intestinal resection
5)Those who have difficulty to participate in this study because of conditions i.e., liver, kidney, or cardiac disease, breathing, endocrinology, metabolism, nervous, or conscious disorder, diabetes (determined by JDA), and other diseases
6)Those with history of cardiovascular diseases
7)Those who regularly use amino acids or protein-enriched foods or beverages for the purpose of maintaining physical fitness, improving exercise function, or dieting
8)Those who have allergies related to test food
9)Those with a history or current history of hepatitis or those with circulatory system disease or severe anemia
10)Those who use medicines, health foods and supplements (including "Food for specified health uses", "Foods with function claims" and "Food with nutrient function claims") constantly, excepting those who can stop them at taking of informed consent
11)Previous experience of poor or worsened health after giving a blood sample
12)Blood donations 200 mL or more in the month before the trial or have plans for making a blood donation 200 mL or more during the trial period
13)Participation in another clinical trial, whether ongoing or within the last four weeks
14)Heavy drinkers and smokers
15)Extremely irregular dietary patterns
16)Late night and irregular shift workers
17)Those who do not wish to provide their consent to the details of the trial explained to them in advance
18)Those who judged that examination responsible doctor is not appropriate for this study participation
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Shiojima |
Organization
Ryusendo Co., Ltd.
Division name
President and CEO
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
y.shiojima@ryusendo.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Takahashi |
Organization
Ryusendo Co., Ltd.
Division name
Development Division
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
Homepage URL
m.takahashi@ryusendo.co.jp
Sponsor or person
Institute
Kyowa Trial Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ryusendo 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
Institutional Review Board of Yamazaki Otolaryngology Vertigo Clinic
Address
14-1-16 Kita 11-jo Nishi, Chuo-ku, Sapporo-shi, Hokkaido 060-0011, Japan
Tel
011-757-3387
s-ito@kyowa-t.com
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
| 2023 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1756464624000148
Number of participants that the trial has enrolled
62
Results
A significant difference was observed in the primary outcome.
Results date posted
| 2024 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Japanese adult
Participant flow
62 participants completed and were incorporated into the analyses.
Adverse events
No adverse effect reported
Outcome measures
Lower limb extensor strength
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055003
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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