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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025265
Receipt No. 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

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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
Email 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
Email Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp

Sponsor
Institute SAPPORO HOLDINGS LTD.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029058

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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