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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009196
Receipt No. 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

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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
Institute TTC
Institute
Department

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
URL(English) https://upload.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


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