UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025265 |
|---|---|
| Receipt number | R000029058 |
| Scientific Title | A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2017/07/13 07:53:12 |
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Basic information
Public title
A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction
Acronym
A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction
Scientific Title
A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction
Scientific Title:Acronym
A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects on serum uric acid level reduction by test food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Serum uric acid level
Key secondary outcomes
1. Blood biochemistry examination
AST (GOT), ALT (GPT), gamma-GT (gamma-GTP), LDL-cholesterol, triglyceride (TG), and creatinine
2. Urinalysis
Uric acid and creatinine
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
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1. Single-dose study
Duration: 1 day
Test materials: Placebo tablets
Administration: After a fasting blood and urine collection, 8 placebo tablets were ingested then take a rich in purine-containing meal. The blood and urine collections require at 2 and 4 hours after meal again.
2. Long-term ingestion study
Duration: 4 weeks
Test materials: Placebo tablets
Administration: Take 8 placebo tablets per day were ingested any time during the day.
Interventions/Control_2
1. Single-dose study
Duration: 1 day
Test materials: 50 mg plant-derived ingredients containing tablets.
Administration: After a fasting blood and urine collection, 8 plant-derived ingredients containing tablets (50 mg/tablet) were ingested then take a rich in purine-containing meal. The blood and urine collections require at 2 and 4 hours after meal again.
2. Long-term ingestion test
Duration: 4 weeks
Test materials: 50 mg plant-derived ingredients containing tablets
Administration: 8 plant-derived ingredients containing tablets (50 mg/tablet) per day were ingested any time during the day.
Interventions/Control_3
1. Single-dose study
Duration: 1 day
Test materials: 50 mg plant-derived ingredients containing tablets and placebo tablets
Administration: After a fasting blood and urine collection, 6 plant-derived ingredients containing tablets (50 mg/tablet) and 2 placebo tablets were ingested then take a rich in purine-containing meal. The blood and urine collections require at 2 and 4 hours after meal again.
2. Long-term ingestion test
Duration: 4 weeks
Test materials: 50 mg plant-derived ingredients containing tablets and placebo tablets
Administration: 6 plant-derived ingredients containing tablets (50 mg/tablet) and 2 placebo tablets per day were ingested any time during a day.
Interventions/Control_4
1. Single-dose study
Duration: 1 day
Test materials: 50 mg plant-derived ingredients containing tablets and placebo tablets
Administration: After a fasting blood and urine collection, 8 plant-derived ingredients containing tablets (50 mg/tablet) and 3 placebo tablets were ingested then take a rich in purine-containing meal. The blood and urine collections require at 2 and 4 hours after meal again.
2. Long-term ingestion test
Duration: 4 weeks
Test materials: 50 mg plant-derived ingredients containing tablets and placebo tablets
Administration: 5 plant-derived ingredients containing tablets (50 mg/tablet) and 3 placebo tablets per day were ingested any time during a day.
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. Healthy Japanese adults of over 20 years old
2. Serum uric acid level was more than 5.0 mg/dL-8.0 mg/dL without gout symptoms
3. Those who received a full explanation of the procedures in the study, and informed consent was documented and signed by all of the participants
Key exclusion criteria
1. Those who are receiving medication and/or treatment such as hyperuricemia, hypertension, diabetes mellitus etc.
2. Those who are allergic to citrus fruits
3. Those who are pregnant, breast-feeding, or are expected to become pregnant during the test period
4. Those who are going to have surgery and/or hospitalization within 2 months before and after the study period of Nov. 2016 to May 2017
5. Others consider as inappropriate for this test by the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko YOSHIKAWA |
Organization
SAPPORO HOLDINGS LTD.
Division name
Group Research and Development Division
Zip code
Address
4-20-1 Ebisu, Shibuya-ku, Tokyo.
TEL
03-5795-1201
Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko YOSHIKAWA |
Organization
SAPPORO HOLDINGS LTD.
Division name
Group Research and Development Division
Zip code
Address
4-20-1 Ebisu, Shibuya-ku, Tokyo.
TEL
03-5795-1201
Homepage URL
Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp
Sponsor or person
Institute
SAPPORO HOLDINGS LTD.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
サッポロホールディングス株式会社本社（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 31 | 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
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
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 13 | Day |
Last modified on
| 2017 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029058
