UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of vegetable juice on lipid metabolism
Title of the study (Brief title)	The effect of vegetable juice on lipid metabolism
Region	Japan

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

Objectives
Narrative objectives1	Exploring the influence on lipid metabolism- by continuous ingection of vegetable juice three times a day for 8 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total cholesterol, LDL cholesterol, Triglyceride(TG)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of 200 mL of vegetable juice three times a day before each meal for 8 weeks
Interventions/Control_2
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	50 years-old <=
Age-upper limit	70 years-old >
Gender	Male
Key inclusion criteria	1. Japanese male healthy volunteers above 50 and below 70 years of age when written informed consent is obtained. 2. Subjects whose abdominal circumference is 85 cm or more at the time of preliminary examination 3. Subjects who have a high LDL cholesterol level at preliminary inspection (As a guide, 120 mg / dL or more) 4. Subjects who have a high TG level at preliminary inspection (As a guide, 100 mg / dL or more, less than 400 mg / dL) 5. Subjects who can visit medical institution on scheduled visit date 6. Subjects who realize the object and contents of the study and submit the written informed consent
Key exclusion criteria	1. Subjects who develop diabetes Fasting blood glucose: 126 mg / dL or more or HbA 1 c: 6.5% or more 2. Subjects who have systolic blood pressure of 180 mmHg or more or diastolic blood pressure of 110 mmHg or more 3. Subjects who have current medical history of serious heart disease (heart failure, myocardial infarction, myocarditis, etc.), liver function disorder or renal disorder injury 4. Subjects who donated 400 mL of blood within 12 weeks before starting ingestion, 200 mL of blood within 4 weeks or donor ingredient donation (plasma component donation and blood platelet component donation) within 2 weeks 5. Subjects who are participating in other examination or within 4 weeks of examination end 6. Subjects who are at risk of having allergic reactions to raw materials of test foods, or to metals 7. Subjects who have experienced a feeling defect or physical condition deterioration due to blood sampling in the past 8. Heavy drinkers(averaged 40 g equivalent amount / day or more in terms of pure alcohol amount) 9. Excessive smokers (average 21 / day or more) 10. Subjects who have constipation (as a guide, twice a week or less) or have chronic diarrhea 11. Subjects with extremely irregular eating habits (extreme food starters, shift workers, etc.) 12. Subjects who take prescribed medicine which would affect the lipid metabolism 13. Subjects who regularly take medicine, functional foods, and/or supplements which would affect the lipid metabolism, excluding those who can stop taking them after informed consent). 14. Subjects who have a history of large surgery on the gastrointestinal tract such as gastrectomy, gastrointestinal suture, intestinal resection (excluding cecal resection) 15. Subjects who are judged as ineligible to participate in the study for other reasons by the principal investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Hirona Miura
Organization	Higashi shinjuku Clinic
Division name	Director
Address	1-11-3, Okubo Shinjuku-ku, Tokyo
TEL	03-6233-8583
Email	koike@meiseikai-cl.com

Public contact
Name of contact person	Junko Fujii
Organization	New Drug Research Center Inc.
Division name	Clinical Research Development
Address	1-7-1 Yurakucho, Chiyoda-ku, Tokyo
TEL	03-6551-2335
Homepage URL
Email	j-fujii@ndrcenter.co.jp

Sponsor
Institute	The KAITEKI Institute, Inc.
Institute
Department

Funding Source
Organization	The KAITEKI Institute, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	医療法人社団 盟生会 東新宿クリニック

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 12 Day
Anticipated trial start date	2017 Year 09 Month 16 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	2017 Year 09 Month 15 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033340