UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005622
Receipt number R000006374
Scientific Title A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHD CHOCOLATE
Date of disclosure of the study information 2011/05/20
Last modified on 2012/10/30 11:00:52

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Basic information

Public title

A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHD CHOCOLATE

Acronym

A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED CHOCOLATE

Scientific Title

A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHD CHOCOLATE

Scientific Title:Acronym

A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED CHOCOLATE

Region

Japan


Condition

Condition

hypercholestemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect on cholesterol reduction and the safety under the consumption of a plant sterol-enriched chocolate for 12 weeks

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bloodchemisty, hematology and physical examination at 4-week, 8-week, 12-week consumption and 4-week after consumption period

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


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

Effectiveness and safety after 12 weeks of
test food consumption compared to before
comsumption

Interventions/Control_2

Effectiveness and safety of 12-week test
food consumption compared to placebo control

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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Subject with total cholesterol serum level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160
mg/dL
2) Subject, aged from 20 to 65 years (bounds included)
3) Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent

Key exclusion criteria

1) Subject taking any hypocholesterolemic
treatment
2) Subfect currently involved in other clinical trial
3) Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months prior to the start of the present study
4) For female subject: pregnancy or possibility of pregnancy, or intention to be pregnant during the study
5) For female subject: breast feeding
6) Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products
7) Subject having sitosterolemia
8) Subject receiving treatment for serious
liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders
9) Subject deemed unsuitable by the investigator

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Kajimoto

Organization

Senrichuo Ekimae Clinic

Division name

Director

Zip code


Address

Senri Life Science Center 3F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka.

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Soiken Inc.

Division name

Department of Clinical Evaluation System

Zip code


Address

Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka.

TEL

06-6871-8888

Homepage URL


Email



Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

Soiken 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

2011 Year 05 Month 20 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

2010 Year 12 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 01 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

2011 Year 05 Month 20 Day

Last modified on

2012 Year 10 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006374


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name