UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016000
Receipt number R000018552
Scientific Title A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Polydextrose A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Date of disclosure of the study information 2014/12/24
Last modified on 2021/02/17 16:29:38

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Basic information

Public title

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Polydextrose
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Acronym

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Polydextrose

Scientific Title

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Polydextrose
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Scientific Title:Acronym

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Polydextrose

Region

Japan


Condition

Condition

No(subjects with fasting serum triglyceride levels 30-199 mg/dL)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of food containing polydextrose for 4 weeks

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Biochemical examination, Hematological examination, urine analysis, vital signs

Key secondary outcomes



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

Food containing polydextrose, 3-fold quantity of recommended daily intake

Interventions/Control_2

Food not containing polydextrose

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)Healthy males and females aged 20 to 64 years old
(2)Subjects whose fasting serum triglyceride levels are from 30 mg/dL to 199 mg/dL
(3)Subjects who can stop drinking from 2 days before each measurement
(4)Subjects who can make self-judgment and are voluntarily giving written informed consent

Key exclusion criteria

(1)Subjects who use medications affecting obesity, hyperlipidemia, lipid metabolism, and so on
(2)Subjects who can't stop using supplements and/or functional foods affecting obesity, hyperlipidemia, lipid metabolism, and so on
(3)Subjects who contract serious diabetes, kidney disease, liver disease, and/or disease needing immediate treatment, and who are taking relevant medicines
(4)Subjects who have a history of digestive disease affecting digestion and absorption, and related surgery
(5)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism
(6)Subjects who have been diagnosed as familial hyperlipidemia
(7)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating
(8)Subjects who have donated blood components and/or blood a volume of 200 mL and over within one month prior to the current study
(9)Subjects who are planning to participate or already participating in other clinical studies
(10)Subjects who are judged as unsuitable for the study by the investigator for other reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name YASUO
Middle name
Last name THO

Organization

Medical Corporation Association KUNWA-KAI AIWA CLINIC

Division name

Medical office

Zip code

343-0827

Address

1-590-1 Kawayanagicho, Koshigaya-shi, Saitama

TEL

048-989-2000

Email

kunwakai@aol.com


Public contact

Name of contact person

1st name Yoshika
Middle name
Last name Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

yoshi@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

TOYO SHINYAKU Co., Ltd

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

AIWA CLINIC institutional review board

Address

1-590-1 Kawayanagicho,Koshigaya-shi, Saitama-ken 343-0827Japan

Tel

048-989-2000

Email

kunwakai@aiwacl.or.jp


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

2014 Year 12 Month 24 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

2014 Year 11 Month 25 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 25 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

2014 Year 12 Month 19 Day

Last modified on

2021 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018552


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name