UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033970
Receipt number R000038734
Scientific Title Effect of the experimental diet on lipid metabolism
Date of disclosure of the study information 2018/09/01
Last modified on 2019/09/01 16:15:20

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Basic information

Public title

Effect of the experimental diet on lipid metabolism

Acronym

Effect on lipid metabolism

Scientific Title

Effect of the experimental diet on lipid metabolism

Scientific Title:Acronym

Effect on lipid metabolism

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prove clinical benefits associated with 12 week daily intake of active test food on blood lipid level.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total blood cholesterol
Blood LDL cholesterol
Blood HDL cholesterol
Blood triglyceride

Key secondary outcomes

Body weight
BMI
Incidence of adverse and of side effects


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake 6 capsules those contain test food three times a day (after each meal), for 12 weeks.

Interventions/Control_2

Intake 6 capsules those contain no test food three times a day (after each meal), for 12 weeks.

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

40 years-old <=

Age-upper limit

60 years-old >=

Gender

Male

Key inclusion criteria

1)Males aged 40 to 60 at resistration.
2) LDL-cholesterol >= 120mg/dL
3) Subjects giving written informed consent.

Key exclusion criteria

1) Subjects who constantly use medicines, supplements having a possibility of affecting test results.
2) Subjects who have previous and/or current medical history of serious disease having a possibility of affecting test results.
3) Subjects who excessive alcohol intake and excess smoker.
4) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
5) Subjects who have previous medical history of drug and/or food (especially gelatin) allergy.
6) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
7) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
8) Males who donated over 400mL blood and/or blood components within the last three month to the current study.
9) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
10) Subjects who are positive for infectious.
11) Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiji Shioda

Organization

SHIODA Life Science Inc.

Division name

President

Zip code


Address

Harks Roppongi Bildg. 6F, 6-15-21 Roppongi, Minato-ku, Tokyo, Japan

TEL

03-6804-5371

Email

shioda@hoshi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Ichinohe

Organization

CPCC Company Limited

Division name

Planning and Sales Department

Zip code


Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5927-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

SHIODA Life Science 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



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 01 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

2018 Year 07 Month 20 Day

Date of IRB

2018 Year 07 Month 20 Day

Anticipated trial start date

2018 Year 09 Month 04 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 08 Month 31 Day

Last modified on

2019 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038734


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name