UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024579
Receipt number 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 10:05:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Suntory Global Innovation Center Ltd.

Institute

Department

Personal name



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

Value
https://center6.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