UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the inhibitory effect of Chrysanthemum Morifolium Flower Extract containing supplement on diet-induced serum uric acid elevation in healthy male subjects
Title of the study (Brief title)	A study to evaluate the inhibitory effect of Chrysanthemum Morifolium Flower Extract containing supplement on serum uric acid
Region	Japan

Condition
Condition	Healthy male volunteers, mild hyperuricemia
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the inhibitory effect of Chrysanthemum Morifolium Flower Extract containing supplement on serum uric acid
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum uric acid level
Key secondary outcomes	Urine uric acid level

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Chrysanthemum Morifolium Flower containing supplement
Interventions/Control_2	Chrysanthemum Morifolium Flower non-containing supplement
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	70 years-old >=
Gender	Male
Key inclusion criteria	Serum uric acid 5.5-8.0 mg/dL
Key exclusion criteria	1) Taking anti-hyperuricemic drugs 2) History of gouty arthritis, gouty node, and/or gouty attack 3) Taking drugs or functional food that may affect serum uric acid level 4) Participation in any clinical trial within 90 days of the commencement of the trial
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroshi Shimoda
Organization	Oryza Oil & Fat Chemical Co., LTD.
Division name	Food Development Dept., R & D Center
Address	1 Numata Kitagata Kitagata-cho, Ichinomiya City,Aichi Pref.
TEL	0586-86-5141
Email	kaihatsu@mri.biglobe.ne.jp

Public contact
Name of contact person	Shoketsu Hitoe
Organization	Oryza Oil & Fat Chemical Co., LTD.
Division name	Food Development Dept., R & D Center
Address	1 Numata Kitagata Kitagata-cho, Ichinomiya City,Aichi Pref.
TEL	0586-86-5141
Homepage URL
Email	kaihatsu@mri.biglobe.ne.jp

Sponsor
Institute	Oryza Oil & Fat Chemical Co., LTD.
Institute
Department

Funding Source
Organization	Food Development Dept., R & D Center
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 11 Day
Anticipated trial start date	2016 Year 06 Month 23 Day
Last follow-up date	2016 Year 07 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 21 Day
Last modified on	2016 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026305