UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation of an excessive consumption of food material - Randomized, double-blind, placebo-controlled parallel group study -
Acronym	Safety evaluation of an excessive consumption of food material
Scientific Title	Safety evaluation of an excessive consumption of food material - Randomized, double-blind, placebo-controlled parallel group study -
Scientific Title:Acronym	Safety evaluation of an excessive consumption of food material
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of excessive consumption of food material for 4 weeks
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Expression rate of side effect, Expression rate of Adverse event , clinical examination items, physiological examination items
Key secondary outcomes

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	Prevention
Type of intervention	Food
Interventions/Control_1	Test food 5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 weeks.
Interventions/Control_2	Control food 5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Males and females equal to or more than 20 years and less than 65 years of age 2)Subjects who visit on schedule days 3)Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria	1)Subjects who BMI >=30.0 kg/m2 or <18.5 kg/m2 2)Subjects who have systolic blood pressure <90 mmHg 3)Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study 4)Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs 5)Subjects who regularly use drugs, health foods, and supplements 6)Females in pregnancy, lactation and scheduled pregnancy during test period. 7)Heavy alcoholic beverager(40g alcohol/day>=), heavy smoker(21 cigarettes/day>=) 8)Subjects who feel bad mood by blood collection in past 9)Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period 10)Night shift worker 11)Don't usually have breakfast 12)Subjects who plan business trip or trip for 10 days or more a month 13)Subjects who have allergy related to the study foods 14)Those who have been diagnosed with chronic constipation 15)Dysphagic person 16)Subjects already participating in other clinical trials 17)Subjects who are ineligible due to physician's judgement
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Ikuo Middle name Last name Fukuhara
Organization	Fukuhara Clinic
Division name	Hospital director
Zip code	061-1351
Address	3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido, Japan
TEL	0123-36-8029
Email	i-feniwa@gray.plala.or.jp

Public contact
Name of contact person	1st name Toyotada Middle name Last name Ashino
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
Zip code	061-1405
Address	452-1 Toiso, Eniwa-shi, Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	t-ashino@ndrcenter.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., Ltd
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukuhara Clinic Clinical Trial Review Committee
Address	1-15, Shimamatsuhigashimachi-3-chome, Eniwa-shi, Hokkaido
Tel	0123-36-8029
Email	d-kameda@mediffom.co.jp

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	2021 Year 04 Month 02 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
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	2021 Year 03 Month 24 Day
Date of IRB	2021 Year 03 Month 22 Day
Anticipated trial start date	2021 Year 04 Month 26 Day
Last follow-up date	2021 Year 06 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 02 Day
Last modified on	2021 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050020