UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025942
Receipt number R000029825
Scientific Title A confirmation study on improvement effect of serum uric acid level by single consumption of the test food
Date of disclosure of the study information 2017/02/03
Last modified on 2020/10/05 18:14:28

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Basic information

Public title

A confirmation study on improvement effect of serum uric acid level by single consumption of the test food

Acronym

A confirmation study on improvement effect of serum uric acid level by single consumption of the test food

Scientific Title

A confirmation study on improvement effect of serum uric acid level by single consumption of the test food

Scientific Title:Acronym

A confirmation study on improvement effect of serum uric acid level by single consumption of the test food

Region

Japan


Condition

Condition

Healthy male adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the influence of rice endosperm protein (REP) for serum uric acid level at consumption of high-purine foods.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

AUC of serum uric acid level during 24-hrs after test food intake.

Key secondary outcomes

Uric acid level in serum at each time point and that in urine collection after test food loading.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of high-purine drink and the suspension which include rice endosperm protein -- Washout 2-week --Intake of high-purine drink and water

Interventions/Control_2

Intake of high-purine drink and water -- Washout 2-week --Intake of high-purine drink and the suspension which include rice endosperm protein

Interventions/Control_3


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) Males whose serum uric acid levels are less than or equal to 7.9mg/dL
(2) Males aged 20 years old and over
(3) Subjects who possible to take a blood sample repeatedly with the passage of time
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

(1) Subjects who have severe disease in liver, kidney, heart, lung, digestive organ, blood, endocrine system or metabolic system.
(2)Subjects who have medical history of gouty arthritis, kidney disease or urinary stone.
(3) Subjects who are received treatment of high blood pressure continuously.
(4)Subjects who are received current treatment for diabetes mellitus.
(5)Subjects who are received a prescription of drugs for hyperlipidemia or blood sugar improvement.
(6) Heavy alcohol drinker.
(7)Subjects who have previous medical history of drug and/or food allergy.
(8)Subjects who participated another test of drug or food within 1-month.
(9)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study.
(10)Subjects who have donated over 400 mL of blood and/or blood components within the last three months prior to the current study.
(11)Shift workers.
(12) These having Food for Specified Health Uses (FOSHU) and/or health food.
(13)Subjects who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

33


Research contact person

Name of lead principal investigator

1st name Suguru
Middle name
Last name Fujiwara

Organization

CPCC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Ichinohe

Organization

CPCC Co.,Ltd.

Division name

Sales & Planning Department

Zip code

101-0047

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

KAMEDA SEIKA CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.jp


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



Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 03 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

2017 Year 01 Month 19 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 04 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

2017 Year 02 Month 01 Day

Last modified on

2020 Year 10 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name