UMIN-CTR Clinical Trial

Public title

A study of effect of food containing plant ingredient on serum uric acid

Acronym

A study of effect of food containing plant ingredient on serum uric acid

Scientific Title

A study of effect of food containing plant ingredient on serum uric acid

Scientific Title:Acronym

A study of effect of food containing plant ingredient on serum uric acid

Region

Japan

Condition

None

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of food containing plant ingredient on serum uric acid

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Serum uric acid level

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of food containing plant ingredient
(Dosage 1) component food (4 weeks).

Interventions/Control_2

Ingestion of food containing plant ingredient (Dosage 2) component food (4 weeks).

Interventions/Control_3

Ingestion of food not-containing plant ingredient (4 weeks)

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Japanese subjects of both sexes above 20 years old- under 65 years old at the point of obtaining informed consent
2)Subjects with serum uric acid level of fasting above 5.0 mg/dL-under7.0 mg/dL as target value at pre-inspection
3)Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.

Key exclusion criteria

1)Subjects who intake health food, supplements, and medical chemical (Refer to exhibit 1 and 2 for specific example of food, supplements, and medical chemical)
2)Subjects who is ineligible for this study due to results of lifestyle questionnaires.
3)Subjects who have risk to develop allergy.
4)Subjects who are under treatment for chronic disorders, or subjects who need treatment with medication for serious disorders
5)Subjects who have serious diabetes, hepatic disorder (liver inflammation), kidney disorder, and cardiac disorder, or subjects who have history of medication for thyroid disorder, adrenal gland disorder, and other metabolic disease
6)Subject who have history of treatment for digestive system that effects on digestion absorption or have history of operation on digestive system
7)Subjects who are ineligible based on clinical laboratory test results and objective measurement prior to the start of ingestion
8)Subjects who participated in other clinical trial within 1 month prior to obtaining informed consent, or subjects who are planning to participate other clinical trial during this study
9)Subjects who performed blood withdrawal or component blood donation of 200 mL within 1 month or over 400 mL within 3 month before the date of obtaining informed consent
10)Subjects who drinks beyond proper quantity consistently
11)Subjects who can not temperance since 3 days prior to the pre-inspection or each inspection
12)Subjects who have history of treatment for drug dependency or alcohol dependency, or currently under the treatment for drug dependency or alcohol dependency
13)Subjects who are willing to become pregnant or lactation during this study
14)Subjects who work at Development and production companies for functional food
15)Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Mai Mizutani

Organization

Kirin Company, Limited

Division name

Research Laboratories for Health Science & Food Technologies Research & Development Division

Zip code

Address

1-17-1,Namamugi,Tsurumi-ku,Yokohama 230-8628 Japan

TEL

080-2049-5763

Email

m-mizutani@kirin.co.jp

Name of contact person

1st name
Middle name
Last name	Shigeru Imai

Organization

CROee. INC

Division name

Evidence Division

Zip code

Address

2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan

TEL

03-5953-2108

Homepage URL

Email

imai@croee.com

Institute

CROee.INC

Institute

Department

Personal name

Organization

Kirin Company, Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

01

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2017

Year

12

Month

22

Day

Date of IRB

Anticipated trial start date

2018

Year

02

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

03

Month

06

Day

Last modified on

2018

Year

03

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036093