UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of long-term consumption of crocetin. :A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Title of the study (Brief title)	Safety evaluation of long-term consumption of crocetin.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of long-term consumption of crocetin.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical examinations Hematological tests Blood biochemistry tests Urinalysis (0, 6, 12 week)
Key secondary outcomes	Questionnaires of subjective symptoms

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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test material: Soft capsule containing 7.5 mg of crocetin One capsule per day
Interventions/Control_2	Duration: 12 weeks Test material: Placebo soft capsule One capsule per 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	Healthy adults of Japanese
Key exclusion criteria	a) At least one previous medical history of malignant tumor, heart failure or myocardial infarction b) Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases c) Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily d) Currently taking medicines and/or herbal medicines e) Those who are allergic to medicines or foods related to the test material of this trial. f) Pregnant women, lactating women, or women who plan to become a pregnant during the trial period. g) Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial h) Others considered as inappropriate for the study by the physician
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

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

Sponsor
Institute	ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization	RIKEN VITAMIN CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medial Clinic.
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	医療法人社団 盛心会 タカラクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 17 Day
Anticipated trial start date	2017 Year 04 Month 19 Day
Last follow-up date	2017 Year 09 Month 09 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Yamashita S, Umigai N, Kakinuma T, Takara T. Safety evaluation of long-term intake of crocetin in healthy adult volunteers: A randomized, double-blind, placebo-controlled, parallel-group comparison trial. Jpn Pharmacol Ther. 2018, 46:801-809.
Other related information

Management information
Registered date	2017 Year 04 Month 18 Day
Last modified on	2018 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031000