UMIN-CTR Clinical Trial

Basic information
Public title	A randomized placebo-controlled double-blind parallel-group trial on lipid metabolic effect of a food ingredient (G-PX)
Acronym	An RCT (randomized controlled trial) on lipid metabolic effect of a food ingredient (G-PX)
Scientific Title	A randomized placebo-controlled double-blind parallel-group trial on lipid metabolic effect of a food ingredient (G-PX)
Scientific Title:Acronym	An RCT (randomized controlled trial) on lipid metabolic effect of a food ingredient (G-PX)
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of the trial is to evaluate variation of lipid-related factors in blood after food intake in healthy Japanese men and women with no disease aged 20 years or older.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the amount of L/H ratio changes with placebo as a control
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	carotenoid
Interventions/Control_2	placebo
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Persons with relatively high oxidized LDL/LDL cholesterol (2) Persons with relatively high LDL cholesterol/HDL cholesterol (LH ratio) (3) Persons with BMI 30 or lower (4) Persons who can visit designated facilities on scheduled visiting dates (5) Persons who fully understood the purpose and content of the trial and gave written consent
Key exclusion criteria	(1) Persons who are receiving any treatment at the time of participation in the trial (2) Pregnant women (including those who are potentially pregnant) or lactating women (3) Smokers (4) Persons who made a blood component donation or whole blood donation of 200 mL within 4 weeks prior to the trial food intake (5) Persons who made a whole blood donation of 400 mL within 16 weeks prior to the trial food intake (6) Persons who underwent blood drawing of over 1000 mL within 48 weeks prior to the trial food intake (7) Persons who are participating in other trials or studies (8) Persons who meet any of the following: 1) Persons with heart, liver or kidney diseases (including complications of other diseases) 2) Persons with medical history of circulatory diseases 3) Persons with diabetes mellitus 4) Persons currently receiving treatment for or with medical history of serious diseases such as cancer or asthma (9) Persons with history of major surgery in the site of gastrointestinal tract such as gastrectomy, gastroenterostomy, or intestinal resection
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kuriki
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of Health Sciences
Zip code	5558502
Address	4-6-5 Utajima, Nishiyodogawa, Osaka 555-8502, JAPAN
TEL	06-6477-8425
Email	takashi.kuriki@glico.com

Public contact
Name of contact person	1st name Satomi Middle name Last name Nakano
Organization	edihas Co., Ltd.
Division name	Division of Clinical Trial Support
Zip code	0600041
Address	2-3-1, Ohodouri-higashi, Chuoo-ku, Sapporo-city, Hokkaido, Japan
TEL	0112527419
Homepage URL
Email	nakano@edihas.co.jp

Sponsor
Institute	Ezaki Glico Co., Ltd.
Institute
Department

Funding Source
Organization	Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tohoku University Graduate School of Agricultural Science / Faculty of Agriculyure
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Utsukushigaoka
Address	Sapporo-city, kiyota-ku, 61-1
Tel	011-882-0111
Email	matsuda@ughp-cpc.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	医療法人波津診療所

Other administrative information
Date of disclosure of the study information	2018 Year 08 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	60
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 06 Month 15 Day
Date of IRB	2018 Year 06 Month 15 Day
Anticipated trial start date	2018 Year 07 Month 21 Day
Last follow-up date	2018 Year 10 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 01 Day
Last modified on	2019 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038301