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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029158
Receipt No. R000033340
Scientific Title The effect of vegetable juice on lipid metabolism
Date of disclosure of the study information 2017/09/16
Last modified on 2018/02/01

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Basic information
Public title The effect of vegetable juice on lipid metabolism
Acronym The effect of vegetable juice on lipid metabolism
Scientific Title The effect of vegetable juice on lipid metabolism
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirona Miura
Organization Higashi shinjuku Clinic
Division name Director
Zip code
Address 1-11-3, Okubo Shinjuku-ku, Tokyo
TEL 03-6233-8583
Email koike@meiseikai-cl.com

Public contact
Name of contact person
1st name
Middle name
Last name Junko Fujii
Organization New Drug Research Center Inc.
Division name Clinical Research Development
Zip code
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)

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 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

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
2017 Year 09 Month 12 Day
Date of IRB
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

Other
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

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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