UMIN-CTR Clinical Trial

Public title

Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.

Acronym

Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.

Scientific Title

Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.

Scientific Title:Acronym

Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.

Region

Japan

Condition

Healthy male subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of present study is to evaluate the effects of melinjo seed extract powder on the level of serum uric acid and research its effective dose.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

serum uric acid level
(at 2-3 weeks and 1 day before the intervention, and after 4, 8, 12 weeks of daily intake.)

Key secondary outcomes

blood test, urinalysis
(at 2-3 weeks and 1 day before the intervention, and after 4, 8, 12 weeks of daily intake.)

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

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral administration of melinjo seed extract powder (100mg/day, 12weeks)

Interventions/Control_2

Oral administration of melinjo seed extract powder (200mg/day, 12weeks)

Interventions/Control_3

Oral administration of melinjo seed extract powder (300mg/day, 12weeks)

Interventions/Control_4

Oral administration of placebo (everyday, 12weeks)

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

70

years-old

>

Gender

Male

Key inclusion criteria

[1] Male subjects whose serum uric acid level is between 6.0 mg/dL and 6.9 mg/dL, and age is between 20 and 69 years old.

Key exclusion criteria

[1] Taking drugs that may affect serum uric acid level.
[2] Individuals who can't stop taking supplement and functional food that may affect serum uric acid level during the test peripd.
[3] Individuals who have an infection needed systemic therapy.
[4] Individuals who are considered that participation for this trial is difficult because of psychiatric symptoms or psychosis.
[5] Individuals who have a uncontrollable diabetes millutus or requiring administration of insulin.
[6] Individuals who are sensitive to test products.
[7] AST >150U/L.
[8] ALT >150U/L.
[9] Total bilirubin >2.0mg/dL.
[10] Individuals who have a kidney disease.
[11] Individuals who have or had a severe allergy or asthma.
[12] Individuals who have a disease needing immediate treatment or serious complication.
[13] Individuals with a digestive organ disease or surgical history having an influence on digestive absorption.
[14] Individuals who have an anamnesis or a history of present illness of drug dependence or alcohol dependence.
[15] Individuals who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that.
[16] Individuals who suffer from gout.
[17] Individuals judged inappropriate for participating the study by the principal

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Shinji Kishi

Organization

Jin-ai University

Division name

Faculty of Human Life Studies, Department of Health and Nutrition.

Zip code

Address

3-1-1, Ohde-cho, Echizen-shi, Fukui-ken 915-8568, Japan

TEL

0778-27-2010

Email

skishi@jindai.ac.jp

Name of contact person

1st name
Middle name
Last name	Tatsuya Sakamoto

Organization

Research Center for Immunological Analysis, Inc.

Division name

none

Zip code

Address

Okayama Research Park Incubation Center 213, 5303, Haga, Kita-Ku, Okayama-shi, Okayama, 701-1221, Ja

TEL

086-286-9333

Homepage URL

Email

info@menekibunseki.com

Institute

Research Center for Immunological Analysis, Inc.

Institute

Department

Personal name

Organization

Yamada Bee Company, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Hosoda Shc co.,Ltd

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

2018

Year

07

Month

01

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

12

Month

29

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

02

Month

17

Day

Last modified on

2017

Year

11

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030096