UMIN-CTR Clinical Trial

Public title

Dose response of effect of test supplement on serum uric acid: A randomized, double blinded, placebo controlled, and parallel group comparison study

Acronym

Dose response of effect of test supplement on serum uric acid level

Scientific Title

Dose response of effect of test supplement on serum uric acid: A randomized, double blinded, placebo controlled, and parallel group comparison study

Scientific Title:Acronym

Dose response of effect of test supplement on serum uric acid level

Region

Japan

Condition

Healthy male adults and hyperuricemia

Classification by specialty

Medicine in general

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aimed to verify the dose response of effect of test supplement on serum uric acid.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Serum uric acid

Key secondary outcomes

Urinary uric acid (creatinine adjusted), Fractional excretion of uric acid

Subgroup analysis using serum uric acid levels and other clinical measurements

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of high-dose test supplement for 4 consecutive weeks

Interventions/Control_2

Ingestion of middle-dose test supplement for 4 consecutive weeks

Interventions/Control_3

Ingestion of low-dose test supplement for 4 consecutive weeks

Interventions/Control_4

Ingestion of placebo for 4 consecutive weeks

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

Key inclusion criteria

1.Subjects aged from 20 to 65 years old
2. Subjects whose serum uric acid levels are included within a range of 6.0 mg/dL to 8.0 mg/dL.

Key exclusion criteria

1. Subjects who usually take some medicine, foods for specified health uses, foods with function claims, health foods, or cosmetics including active ingredients
2. Subjects who have been taking foods affecting the study results once a week or more
3. Subjects who have gout in the past or are currently receiving treatment for hyperuricemia or gout (including exercise therapy, dietary guidance)
4. Subjects who are under treatment or have history of diseases (urinary stone, kidney stone, rheumatoid arthritis) which may influence the outcome of the study
5. Subjects who routinely use analgesics (non-steroidal analgesics, steroidal analgesics, etc.).
6.Subjects who habitually do intense exercise such as marathon
7. Subjects who cannot carry out the procedures of various inspections to be carried out during the research as specified.
8. Subjects who have diseases requiring continuous medication, or serious medical history who needed medication therapy
9. Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
10. Subjects with allergies to the test food in the study
11. Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
12. Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
13. Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
14. Subjects who are judged as unsuitable for the study by the investigator for other reason

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Kei Yui

Organization

FANCL Corporation

Division name

Research Institute, Health science research center

Zip code

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

045-820-3755

Email

ke-yui@fancl.co.jp

Name of contact person

1st name
Middle name
Last name	Hiroyasu Shimada

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan

TEL

03-5459-5329

Homepage URL

Email

h.shimada@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd.

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

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

12

Month

09

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

2017

Year

11

Month

30

Day

Date of IRB

Anticipated trial start date

2017

Year

12

Month

09

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

12

Month

06

Day

Last modified on

2018

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034557