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

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.

Scientific Title:Acronym

PGX clinical study in Japan

Region

Japan


Condition

Condition

Mildly obese metabolic syndrome subjects

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


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

2

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

60


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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name