UMIN-CTR Clinical Trial

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

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Total cholesterol, LDL cholesterol, Triglyceride(TG)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The KAITEKI Institute, Inc.

Institute

Department

Personal name

Organization

The KAITEKI Institute, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団 盟生会 東新宿クリニック

Date of disclosure of the study information

2017

Year

09

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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