UMIN-CTR Clinical Trial

Public title

Effect of Intake of a Food Containing Peucedanum japonicum Root Extract on Uric Acid Levels.

Acronym

Effect of Intake of a Food Containing Peucedanum japonicum Root Extract on Uric Acid Levels.

Scientific Title

Effect of Intake of a Food Containing Peucedanum japonicum Root Extract on Uric Acid Levels.

Scientific Title:Acronym

Effect of Intake of a Food Containing Peucedanum japonicum Root Extract on Uric Acid Levels.

Region

Japan

Condition

No

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine safety and efficacy of intake of a food containing Peucedanum japonicum root extract on uric acid levels.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Uric acid level (Week 0 , Week 12 and 4 weeks after the end of intake of test food)

Key secondary outcomes

*Secondary outcomes
[1] Quality of life related survey with wrist-watch (Fitbit)(1)
[2] Japanese translation of profile of mood states (2)
[3] Subjective questionnaire (2)
[4] Brief-type self-administered diet history questionnaire (3)

*Safety
[1] Blood pressure, pulsation (3)
[2] Weight, body fat percentage, BMI(3)
[3] Hematologic test (3)
[4] Blood biochemical test (3)
[5] Urine analysis (3)
[6] Subject's diary (1)
[7] Doctor's questions (3)
[8] Adverse events: number of cases and expression rate of adverse events (4)

(1): Week 0 to the last day of the test
(2): Week 0 and Week 12
(3): Week 0 , Week 12 and 4 weeks after the end of intake of test food
(4): Week 12 and 4 weeks after the end of intake of test food

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

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of test food (Once a day; 12 weeks).

Interventions/Control_2

Oral intake of placebo food (Once a day; 12 weeks).

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

Key inclusion criteria

[1]Healthy Japanese males aged 20-64 years.
[2]Subjects who are healthy and have no chronic physical disease.
[3]Subjects whose uric acid levels are 6.5 mg/dL-7.9 mg/dL.
[4]Subjects whose written informed consent has been obtained after explanation of this study.
[5]Subjects who can have an examination on a designated check day.
[6]Subjects who are judged appropriate for the study by the principal.

Key exclusion criteria

[1]Subjects using medicines
[2]Subjects having a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia
[3]Subjects having a history of disease of liver, kidney, heart, lung, blood
[4]Subjects having digestive disease
[5]Subjects having hyperuricemia, gout, urinary tract stones, kidney stones, or rheumatoid arthritis
[6]Subjects having drugs within 3 month (excludes cases of headaches, colds, etc.)
[7]Subjects having allergies to foods and medicines
[8]Subjects who fall under any of the following criteria when using a wrist-watch
Subjects
(1)With photosensitive medication
(2)Having epilepsy or sensitivity to flashing lights
(3)With poor blood circulation or who bruise easily
(4)With tendonitis, carpal tunnel syndrome, or other musculoskeletal disorders
(5)Having allergies to rubber or metal
(6)With skin diseases
[9]Subjects having a habit of exercising at least 3 times a week
[10]Subjects having a habit of intense exercise such as marathons or strength training
[11]Subjects whose BMI is over 30kg/m2
[12]Subjects who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[13]Subjects who continuously intake of functional foods, health foods, supplements and beverages containing Chinese herbal medicines, Peucedanum japonicum and medicinal herbs
[14]Subjects who continuously intake of functional foods, health foods, supplements and beverages that profess the effect for uric acid
[15]Heavy drinker (expressed in an amount of alcohol: over 40g/day)
[16]Subjects who cannot use application or smartphone for administrating the data of wrist-watch
[17]Subjects who cannot always ware wrist-watch
[18]Subjects with changing life style
[19]Shift worker or night worker
[20]Subjects who participated in other clinical studies in the past 3 months
[21]Subjects who or whose family works for a company that commodify health and functional foods
[22]Subjects who are judged inappropriate for the study by the principal

Target sample size

40

Name of lead principal investigator

1st name	Takahiro
Middle name
Last name	Ono

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinc

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Maruzen Pharmaceuticals Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81528382485

Email

i.takahashi@tes-h.co.jp

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

2022

Year

07

Month

22

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

No longer recruiting

Date of protocol fixation

2022

Year

06

Month

28

Day

Date of IRB

2022

Year

06

Month

29

Day

Anticipated trial start date

2022

Year

08

Month

11

Day

Last follow-up date

2022

Year

12

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

07

Month

22

Day

Last modified on

2022

Year

08

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055120