UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on the serum uric acid level
Acronym	Effects of consumption of the test food on the serum uric acid level
Scientific Title	Effects of consumption of the test food on the serum uric acid level: A randomized, double-blind, placebo-controlled, parallel-group comparison trial
Scientific Title:Acronym	Effects of consumption of the test food on the serum uric acid level
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effect of single dose and 12-week consumption of the test food on the serum uric acid level
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The measured value of the serum uric acid level at 12 weeks after consumption
Key secondary outcomes	1. The measured value of the serum uric acid level at four weeks after consumption 2. The amount of changes of the measured values of the serum uric acid level between screening and at four and 12 weeks after consumption 3. The IAUC and Cmax of the serum uric acid level at the start date of the test food consumption (0w) 4. The measured values and changes from before taking the loading food of the serum uric acid level at one, two, three, and four hours after taking the loading food at 0w

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test food: Plant extract Loading food: Nucleic acid containing soup Administration: Take one capsule, once a day after breakfast (take one capsule within 20 minutes after taking the loading food at the start date of consumption). Take the loading food by dissolving it in 180 mL of hot water. *If you forget to take the tablets, take tablets as soon as you remember during the day.
Interventions/Control_2	Duration: 12 weeks Test food: Placebo Loading food: Nucleic acid containing soup Administration: Take one capsule, once a day after breakfast (take one capsule within 20 minutes after taking the loading food at the start date of consumption). Take the loading food by dissolving it in 180 mL of hot water. *If you forget to take the tablets, take tablets as soon as you remember during the day.
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 and Female
Key inclusion criteria	1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects whose serum uric acid levels are 6.0 mg/dL or more and 7.9 mg/dL or less (among them, more than 22 subjects must be 6.0 mg/dL or more and 7.0 mg/dL or less in their uric acid levels)
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects who have had symptoms of gout 6. Subjects who work late-night shift and have an erratic lifestyle 7. Subjects who are most likely to eat and drink to excess during the New Year's holiday 8. Subjects who are currently taking medications (including herbal medicines) and supplements 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, breast-feeding, or planning to become pregnant 11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 12. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Takara
Organization	Medical Corporation Seishinkai, Takara Clinic
Division name	Director
Zip code	141-0022
Address	9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL	03-5793-3623
Email	t-takara@takara-clinic.com

Public contact
Name of contact person	1st name Naoko Middle name Last name Suzuki
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Oryza Oil & Fat Chemical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	IRB@takara-clinic.com

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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 30 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	44
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	2020 Year 10 Month 27 Day
Date of IRB	2020 Year 10 Month 27 Day
Anticipated trial start date	2020 Year 11 Month 02 Day
Last follow-up date	2021 Year 05 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 02 Day
Last modified on	2021 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048316