UMIN-CTR Clinical Trial

Public title

Study of effect of food containing plant ingredient on postprandial serum uric acid

Acronym

Study of food containing plant ingredient on postprandial serum uric acid

Scientific Title

Study of effect of food containing plant ingredient on postprandial serum uric acid

Scientific Title:Acronym

Study of food containing plant ingredient on postprandial serum uric acid

Region

Japan

Condition

none

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

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

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Serum uric acid

Key secondary outcomes

Urinary uric acid

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Food containing plant ingredient, 1 food

Interventions/Control_2

Food not containing plant ingredient, 1 food

Interventions/Control_3

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)(Healthy) individuals who are the age of 20 to less than the age of 65 years old.
(2)Individuals whose fasting serum uric acid levels are from 6.0 mg/dL to 7.0 mg/dL.
(3)Individuals giving written informed consent.

Key exclusion criteria

(1)Individuals who use oral medication or supplements or functional foods affecting uric acid metabolism.
(2)Individuals who is not suitable for subjects by pre-test questionnaire.
(3)Individuals who declare the allergy symptoms against test diets.
(4)Individuals who have a chronic disease and use medicines continuously.
(5)Individuals who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(6)Individuals who have a history of digestive disease affecting digestion and absorption.
(7)Individuals who are judged as unsuitable for the study based on the results of blood test.
(8)Individuals who are planned to participate in other clinical study.
(9)Individuals who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study or over 400 mL of blood and/or blood component within the last three months prior to the current study.
(10)Individuals with excessive alcohol-drinking behaviors (over 20 g alcohol/day).
(11)Individuals who can't stop drinking for 3 days until the pre-check day and check days.
(12)Individuals who is diagnosed as severe anemia and not suitable for frequent collection of blood.
(13)Individuals who have under treatment or a history of drug addiction and/or alcoholism.
(14)Individuals who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(15)Individuals who are working for a functional food company.
(16)Individuals who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Jiro Saito

Organization

Medical station clinic

Division name

Medical station clinic

Zip code

Address

3-12-8 Takaban Meguro-ku, Tokyo

TEL

03-6271-9140

Email

j.saito@med-station.jp

Name of contact person

1st name
Middle name
Last name	Teruo Saito

Organization

TTC Co., Ltd

Division name

Site Management Organization Division

Zip code

Address

1-10-10 Ebisu-nishi, Shibuya-ku, Tokyo

TEL

03-6455-0880

Homepage URL

Email

t.saito@ttc-smo.jp

Institute

TTC Corporation

Institute

Department

Personal name

Organization

Kirin Co., Ltd.

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

2017

Year

04

Month

29

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

Completed

Date of protocol fixation

2016

Year

01

Month

28

Day

Date of IRB

Anticipated trial start date

2016

Year

03

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Protocol No. 27055

Registered date

2016

Year

03

Month

15

Day

Last modified on

2017

Year

03

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024778