UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029158
Receipt number 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 11:55:41

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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 or person

Institute

The KAITEKI Institute, Inc.

Institute

Department

Personal name



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

Value
https://center6.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