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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024579
Receipt No. R000028288
Scientific Title A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.
Date of disclosure of the study information 2016/10/31
Last modified on 2017/04/28

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Basic information
Public title A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.
Acronym A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.
Scientific Title A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.
Scientific Title:Acronym A study evaluating the effect of single-dose of botanical ingredient-containing food on the serum uric acid level.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to monitor the changes in serum uric acid level after single-dose of botanical ingredient-containing food, which will clarify the effective dose preliminarily.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy : Area under the curve of serum uric acid level.
Safety : Incidence of adverse effects
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 At the first term(Day1), subjects take test food 1. After 6-days of washout, at the second term(Day8), subjects take either (1)test food 2 or (2)placebo. After 6-days of washout, at the third term(Day15), subjects take the opposite food of the second term. (For example, subjects should take placebo if they take test food 2 at the second term.)
In each time, subjects take Inosine 5'-Monophosphate Disodium Salt with cold or hot water 10 mins after intake of capsules.
Interventions/Control_2 At the first term(Day1), subjects take test food 2. After 6-days of washout, at the second term(Day8), subjects take either (1)placebo or (2)test food 1. After 6-days of washout, at the third term(Day15), subjects take the opposite food of the second term.
In each time, subjects take Inosine 5'-Monophosphate Disodium Salt with cold or hot water 10 mins after intake of capsules.
Interventions/Control_3 At the first term(Day1), subjects take placebo. After 6-days of washout, at the second term(Day8), subjects take either (1)test food 1 or (2)test food 2. After 6-days of washout, at the third term(Day15), subjects take the opposite food of the second term.
In each time, subjects take Inosine 5'-Monophosphate Disodium Salt with cold or hot water 10 mins after intake of capsules.
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
Key inclusion criteria (1)Healthy male subjects aged 20 years old or more.
(2)Subjects with serum uric acid level more than or equal to 7.1 mg/dL, and less than 9.0 mg/dL.
(3)Subjects who can visit hospital on the designated day.
(4)Subjects who agree with the given description and express written informed consent.
Key exclusion criteria (1)Subjects with symptom of gouty arthritis or gouty node.
(2)Subjects with serum uric acid level more than or equal to 8.0 mg/dL, who are suffered from complications such as kidney damage, urinary stone, hypertension, ischemic cardiac disease, and diabetes.
(3)Subjects with UUA/UCr less than or equal to 0.40, where UUA and UCr stand for urinary uric acid and urinary creatinine level, respectively.
(4)Subjects whose systolic blood pressure is less than 90mmHg.
(5)Subjects who donated more than 200 mL of blood and/or blood components within the past four weeks prior to the current study.
(6)Subjects who donated more than 400 mL of blood within the last three months prior to the current study.
(7)Subjects whose accumulated amount of donated blood would excess 1200 mL over the past 12 months, if the amount of blood sampling in the current study is added.
(8)Subjects who are participating in other clinical studies, or who finished the clinical study within the last four weeks.
(9)Subjects with disease on heart, liver, or kidney.
(10)Subjects with a previous history of disease on circulatory organs.
(11)Subjects diagnosed with diabetes.
(12)Subjects who have allergic reaction to drug medicine and food.
(13)Subjects who drink alcohol a lot and smoke a lot.
(14)Subjects who have an irregular eating pattern.
(15)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
(16)Subjects who have tested positive for infectious disease
(17)Subjects who have difficulty in swallowing.
(18)Subjects who are judged as unsuitable for the current study by the principal investigator for other reasons.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihito Murayama
Organization Suntory Global Innovation Center Ltd.
Division name Innovation Development Department
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL 050-3182-0588
Email Norihito_Murayama@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Fukizawa
Organization Suntory Global Innovation Center Ltd.
Division name Innovation Development Department
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL 050-3182-0595
Homepage URL
Email Shinya_Fukizawa@suntory.co.jp

Sponsor
Institute Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 チヨダパラメディカルケアクリニック(東京都)/Chiyoda Paramedical Care Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2016 Year 10 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 10 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 27 Day
Last modified on
2017 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028288

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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