UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000009196
Receipt number	R000010798
Scientific Title	Effect of the intake of PGX, a novel soluble viscous polysaccharide complex, on Insulin / Cholesterol / Triglycerides and Blood Sugar levels as well as body mass change over 14 weeks in Japanese subjects. A randomised controlled study.
Date of disclosure of the study information	2012/10/26
Last modified on	2012/10/26 20:48:25

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Basic information

Public title

Effect of the intake of PGX, a novel soluble viscous polysaccharide complex, on Insulin / Cholesterol / Triglycerides and Blood Sugar levels as well as body mass change over 14 weeks in Japanese subjects.
A randomised controlled study.

Acronym

PGX clinical study in Japan

Scientific Title

Scientific Title:Acronym

PGX clinical study in Japan

Region

Japan

Condition

Mildly obese metabolic syndrome subjects

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To determine in a randomised, double-blind, clinical study if PGX, a food ingredient, may help in Metabolic Syndrome Insulin / Cholesterol / Triglycerides and Blood Sugar levels and body mass management of 60 males and females (approximately 30 each), aged 20 to 65 when ingested for 14 weeks in divided doses to a maximum dose of 15g/day.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

BMI (body weight), waist and hip circumferences and CT (areas of body mass and subcutaneous fat)

Key secondary outcomes

serum lipids (TG, TC, HDL-C and LDL-C), OGTT values (blood sugar and insulin), BP (systolic and diastolic) and pulse rate

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

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

PGX is taken for 97 days.

Interventions/Control_2

Placebo is taken for 97 days.

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) Males and females aged 20 to 65
(2) Those with BMI ranging between 25 and 30 at the time of selection visit
(3) Those with body weight below 100 kg

Key exclusion criteria

(1) Those exercising to slim down, those taking health foods for dieting, or who are taking FOSHU or health foods in relation to body mass
(2) Those taking medicines, FOSHU or
health foods possibly to affect the levels of serum lipids and blood sugar
(3) Those under treatment for hyperlipemia,
diabetes or obesity
(4) Those who may possibly develop
allergic reactions associated with the test products
(5) Those having a disease necessitating
regular medication or a history of serious diseases for which medication was needed
(6) Those participating in another clinical
study at the beginning of this study or
who are contemplating entering into one during the course of this study
(7) Those who are pregnant or
breastfeeding during the study period
(8) Those who are judged by the principal
investigator as inadequate for this study for any other reasons

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yoshitaka Iwama, M.D.

Organization

Nihonbashi cardiovascular Clinic, Director

Division name

None

Zip code

Address

13-4, Kodenmachou, Chuou-ku, Tokyo 103-0001, kyoudou Bldg.

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name Muneaki Iizuka

Organization

Total Technological Consultant Co., Ltd.(TTC)

Division name

Clinical Research Planning Dept.

Zip code

Address

1-20-2, Ebisu Nishi, Shibuya-ku, Tokyo 150-0021, Seibu Shinyokinko Ebisu Bldg

TEL

03-5459-5329

Homepage URL

Email

m.iizuka@ttc-tokyo.co.jp

Sponsor or person

Institute

TTC

Institute

Department

Personal name

Funding Source

Organization

INOVOBIOLOGIC Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Canada

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 26 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 24 Day

Date of IRB

Anticipated trial start date

2011 Year 01 Month 07 Day

Last follow-up date

2011 Year 05 Month 28 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2012 Year 10 Month 26 Day

Last modified on

2012 Year 10 Month 26 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010798

1st name
Middle name
Last name	Yoshitaka Iwama, M.D.