UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027038
Receipt number R000030997
Scientific Title Safety evaluation of excessive consumption of crocetin.:A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Date of disclosure of the study information 2018/04/18
Last modified on 2018/06/28 16:32:26

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Basic information

Public title

Safety evaluation of excessive consumption of crocetin.:A randomized, double-blind, placebo-controlled, parallel-group comparison trial.

Acronym

Safety evaluation of excessive consumption of crocetin.

Scientific Title

Safety evaluation of excessive consumption of crocetin.:A randomized, double-blind, placebo-controlled, parallel-group comparison trial.

Scientific Title:Acronym

Safety evaluation of excessive 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 excessive 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, 2, 4 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: 4 weeks
Test material: Soft capsule containing 7.5 mg of crocetin.
Five capsules per day

Interventions/Control_2

Duration: 4 weeks
Test material: Placebo soft capsule
Five capsules 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

1st name
Middle name
Last name Kazuo YAMAMOTO

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code


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

1st name
Middle name
Last name Naoko SUZUKI

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code


Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO, Inc.

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Yamashita S, Umigai N, Kakinuma T, Takara T. Safety evaluation of excessive intake of crocetin in healthy adult volunteers:A randomized, double-blind, placebo-controlled, parallel-group comparison trial. Jpn Pharmacol Ther. 2018, 46:393-401

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

2017 Year 04 Month 17 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 19 Day

Last follow-up date

2017 Year 07 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2017 Year 08 Month 08 Day


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030997


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name