UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the experimental diet on lipid metabolism
Acronym	Effect on lipid metabolism
Scientific Title	Effect of the experimental diet on lipid metabolism
Scientific Title:Acronym	Effect on lipid metabolism
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove clinical benefits associated with 12 week daily intake of active test food on blood lipid level.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total blood cholesterol Blood LDL cholesterol Blood HDL cholesterol Blood triglyceride
Key secondary outcomes	Body weight BMI Incidence of adverse and of side effects

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	Intake 6 capsules those contain test food three times a day (after each meal), for 12 weeks.
Interventions/Control_2	Intake 6 capsules those contain no test food three times a day (after each meal), for 12 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	40 years-old <=
Age-upper limit	60 years-old >=
Gender	Male
Key inclusion criteria	1)Males aged 40 to 60 at resistration. 2) LDL-cholesterol >= 120mg/dL 3) Subjects giving written informed consent.
Key exclusion criteria	1) Subjects who constantly use medicines, supplements having a possibility of affecting test results. 2) Subjects who have previous and/or current medical history of serious disease having a possibility of affecting test results. 3) Subjects who excessive alcohol intake and excess smoker. 4) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 5) Subjects who have previous medical history of drug and/or food (especially gelatin) allergy. 6) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 7) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. 8) Males who donated over 400mL blood and/or blood components within the last three month to the current study. 9) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 10) Subjects who are positive for infectious. 11) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seiji Shioda
Organization	SHIODA Life Science Inc.
Division name	President
Zip code
Address	Harks Roppongi Bildg. 6F, 6-15-21 Roppongi, Minato-ku, Tokyo, Japan
TEL	03-6804-5371
Email	shioda@hoshi.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Planning and Sales Department
Zip code
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5927-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	SHIODA Life Science Inc.
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
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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 01 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	2018 Year 07 Month 20 Day
Date of IRB	2018 Year 07 Month 20 Day
Anticipated trial start date	2018 Year 09 Month 04 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 31 Day
Last modified on	2019 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038734