UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025265
Receipt number R000029058
Scientific Title A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction
Date of disclosure of the study information 2018/03/31
Last modified on 2017/07/13 07:53:12

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Basic information

Public title

A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction

Acronym

A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction

Scientific Title

A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction

Scientific Title:Acronym

A verification study for plant-derived ingredients containing food effects on serum uric acid level reduction

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects on serum uric acid level reduction by test food

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. Serum uric acid level

Key secondary outcomes

1. Blood biochemistry examination
AST (GOT), ALT (GPT), gamma-GT (gamma-GTP), LDL-cholesterol, triglyceride (TG), and creatinine

2. Urinalysis
Uric acid and creatinine


Base

Study type

Interventional


Study design

Basic design

Parallel

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

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

1. Single-dose study
Duration: 1 day
Test materials: Placebo tablets
Administration: After a fasting blood and urine collection, 8 placebo tablets were ingested then take a rich in purine-containing meal. The blood and urine collections require at 2 and 4 hours after meal again.

2. Long-term ingestion study
Duration: 4 weeks
Test materials: Placebo tablets
Administration: Take 8 placebo tablets per day were ingested any time during the day.

Interventions/Control_2

1. Single-dose study
Duration: 1 day
Test materials: 50 mg plant-derived ingredients containing tablets.
Administration: After a fasting blood and urine collection, 8 plant-derived ingredients containing tablets (50 mg/tablet) were ingested then take a rich in purine-containing meal. The blood and urine collections require at 2 and 4 hours after meal again.

2. Long-term ingestion test
Duration: 4 weeks
Test materials: 50 mg plant-derived ingredients containing tablets
Administration: 8 plant-derived ingredients containing tablets (50 mg/tablet) per day were ingested any time during the day.

Interventions/Control_3

1. Single-dose study
Duration: 1 day
Test materials: 50 mg plant-derived ingredients containing tablets and placebo tablets
Administration: After a fasting blood and urine collection, 6 plant-derived ingredients containing tablets (50 mg/tablet) and 2 placebo tablets were ingested then take a rich in purine-containing meal. The blood and urine collections require at 2 and 4 hours after meal again.

2. Long-term ingestion test
Duration: 4 weeks
Test materials: 50 mg plant-derived ingredients containing tablets and placebo tablets
Administration: 6 plant-derived ingredients containing tablets (50 mg/tablet) and 2 placebo tablets per day were ingested any time during a day.

Interventions/Control_4

1. Single-dose study
Duration: 1 day
Test materials: 50 mg plant-derived ingredients containing tablets and placebo tablets
Administration: After a fasting blood and urine collection, 8 plant-derived ingredients containing tablets (50 mg/tablet) and 3 placebo tablets were ingested then take a rich in purine-containing meal. The blood and urine collections require at 2 and 4 hours after meal again.

2. Long-term ingestion test
Duration: 4 weeks
Test materials: 50 mg plant-derived ingredients containing tablets and placebo tablets
Administration: 5 plant-derived ingredients containing tablets (50 mg/tablet) and 3 placebo tablets per day were ingested any time during a day.

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 and Female

Key inclusion criteria

1. Healthy Japanese adults of over 20 years old

2. Serum uric acid level was more than 5.0 mg/dL-8.0 mg/dL without gout symptoms

3. Those who received a full explanation of the procedures in the study, and informed consent was documented and signed by all of the participants

Key exclusion criteria

1. Those who are receiving medication and/or treatment such as hyperuricemia, hypertension, diabetes mellitus etc.

2. Those who are allergic to citrus fruits

3. Those who are pregnant, breast-feeding, or are expected to become pregnant during the test period

4. Those who are going to have surgery and/or hospitalization within 2 months before and after the study period of Nov. 2016 to May 2017

5. Others consider as inappropriate for this test by the physician

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko YOSHIKAWA

Organization

SAPPORO HOLDINGS LTD.

Division name

Group Research and Development Division

Zip code


Address

4-20-1 Ebisu, Shibuya-ku, Tokyo.

TEL

03-5795-1201

Email

Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiko YOSHIKAWA

Organization

SAPPORO HOLDINGS LTD.

Division name

Group Research and Development Division

Zip code


Address

4-20-1 Ebisu, Shibuya-ku, Tokyo.

TEL

03-5795-1201

Homepage URL


Email

Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp


Sponsor or person

Institute

SAPPORO HOLDINGS LTD.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

サッポロホールディングス株式会社本社(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 03 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 12 Month 12 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 11 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 06 Month 30 Day

Date trial data considered complete

2017 Year 06 Month 30 Day

Date analysis concluded

2017 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 12 Month 13 Day

Last modified on

2017 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029058


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name