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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033586
Receipt No. R000038301
Official scientific title of the study A randomized placebo-controlled double-blind parallel-group trial on lipid metabolic effect of a food ingredient (G-PX)
Date of disclosure of the study information 2018/08/01
Last modified on 2018/08/01

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Basic information
Official scientific title of the study A randomized placebo-controlled double-blind parallel-group trial on lipid metabolic effect of a food ingredient (G-PX)
Title of the study (Brief title) 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 Takashi Kuriki
Organization Ezaki Glico Co., Ltd.
Division name Institute of Health Sciences
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 Satomi Nakano
Organization edihas Co., Ltd.
Division name Division of Clinical Trial Support
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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 06 Month 15 Day
Anticipated trial start date
2018 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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