UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035298 |
|---|---|
| Receipt number | R000040200 |
| Scientific Title | A verification study for the effect of the food containing plant-derived ingredients intake on uric acid level: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2019/09/30 |
| Last modified on | 2020/03/24 12:34:56 |
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Basic information
Public title
A verification study for the effect of the food containing plant-derived ingredients intake on uric acid level: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
A verification study for the effect of the food containing plant-derived ingredients intake on uric acid level
Scientific Title
A verification study for the effect of the food containing plant-derived ingredients intake on uric acid level: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
A verification study for the effect of the food containing plant-derived ingredients intake on uric acid level
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of consumption of the test food for 12 weeks on the serum uric acid level
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum uric acid level
*Measure the level at screening (before consumption) and 4, 8, and 12 weeks after consumption and calculate the amount of change.
Key secondary outcomes
1. Urinary uric acid level
2. Urinary creatinine level
3. Urinary uric acid/urinary creatinine ratio
4. Subjective symptoms (the Likert scale)
*1-4Measure the values and levels at screening (before consumption) and 4, 8, and 12 weeks after consumption and calculate the amount of change.
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Tablet containing plant-derived ingredients
Administration: Take 4 tablets, once per day at any time during the day.
Interventions/Control_2
Duration: 12 weeks
Test food: Placebo tablets
Administration: Take 4 tablets, once per day at any time during the 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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy subjects
2. Japanese adult subjects
3. Subjects who are determined as eligible to participate in the study by the physician
4. Subjects who are between >=6.1 mg/dL and <7.0 mg/dL, or >=7.0 mg/dL and <=7.9 mg/dL in serum uric acid level
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hyperuricemia, obesity (based on the standard definition by the Japan Society for the Study of Obesity), or any other chronic diseases
4. Subjects who have had symptoms of gout
5. Subjects who work late-night shift or are irregular of their life-styles
6. Subjects who excessively exercise
7. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional foods/beverages in daily
8. Subjects who are currently taking medications (including herbal medicines) and supplement. Particularly, diosmin, anticoagulant drugs, antiplatelet drugs, antihypertensive drugs (celiprolol hydrochloride, diltiazem hydrochloride, and etc.), diazepam, central nervous system depressant, and vasodilator drugs (verapamil)
9. Subjects who are an allergic reaction to medications and/or products that contain the study ingredients, particularly citrus.
10. Subjects who are pregnant, lactation, or planning to become pregnant
11. Subjects who have been enrolled in another clinical study within the last three months prior to signing informed consent for the current study or plan to enroll in anther clinical study during study period
12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Sapporo Holdings Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
info@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 30 | 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
166
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
| 2018 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040200
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| Registered date | File name |
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