UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031272
Receipt number R000035706
Scientific Title Safety evaluation study of excessive consumption of dietary fiber in carbonated water
Date of disclosure of the study information 2018/12/28
Last modified on 2019/08/23 11:54:55

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Basic information

Public title

Safety evaluation study of excessive consumption of dietary fiber in carbonated water

Acronym

Safety evaluation study of excessive consumption of dietary fiber in carbonated water

Scientific Title

Safety evaluation study of excessive consumption of dietary fiber in carbonated water

Scientific Title:Acronym

Safety evaluation study of excessive consumption of dietary fiber in carbonated water

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of 3-fold dietary fiber of the recommended daily intake in carbonated water.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety evaluation items: Examination by a physician in charge, Physical examination findings, Clinical laboratory findings (Hematological test, Biochemical test, Urine analysis), Subjective symptoms

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of 3-fold dietary fiber of the recommended daily intake in test food for 4 weeks.

Interventions/Control_2


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

70 years-old >

Gender

Male and Female

Key inclusion criteria

(1)Japanese adult male and female from 20 to 69 years old at the time of acquiring consent.

(2)Healthy subjects whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening, or subjects with triglyceride values from 150 - 199 mg/dL whose physical examination findings and clinical laboratory findings other than triglyceride value do not deviate greatly from the normal values at the time of screening.

(3)Subjects who are available at every designated hospital visit.

(4)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.

Key exclusion criteria

(1)Subjects with history of serious diseases or subjects with hepatic, renal, cardiac or organ disorders, diabetes, or other serious diseases.

(2)Subjects with a surgical history of digestive system (except appendicectomy).

(3)Subjects with chronic diseases under treatment.

(4)Subjects who are pregnant or lactating, or intend to become pregnant during the study.

(5)Subjects who consume excessive alcohol (equivalent to more than 540 mL/day of sake or 1,500 mL/day of 5% beer or such) for 5 days or more per week.

(6)Subjects who are aware of having weak stomach or difficulties of taking blended tea beverages.

(7)Subjects judged as unsuitable for the study by principal investigator with other reasons.

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Kazuhiko
Middle name
Last name Takano

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Clinical Pharmacology Center

Zip code

004-0839

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan

TEL

011-882-0111

Email

wakimoto@ughp-cpc.jp


Public contact

Name of contact person

1st name Ryota
Middle name
Last name Wakimoto

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Clinical Pharmacology Center

Zip code

004-0839

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan

TEL

011-882-0111

Homepage URL


Email

wakimoto@ughp-cpc.jp


Sponsor or person

Institute

Medical Corporation Hokubukai Utsukushigaoka Hospital

Institute

Department

Personal name



Funding Source

Organization

Fukuren Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital IRB

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan

Tel

011-881-0111

Email

wakimoto@ughp-cpc.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

医療法人北武会 美しが丘病院


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 28 Day


Related information

URL releasing protocol

Safety evaluation study of excessive consumption of dietary fiber in carbonated water

Publication of results

Unpublished


Result

URL related to results and publications

Safety was confirmed.

Number of participants that the trial has enrolled

16

Results

Safety was confirmed.

Results date posted

2019 Year 08 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

(1) Japanese adult male and female from 20 to 69 years old at the time of acquiring consent.
(2) Healthy subjects whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening, or subjects with triglyceride values from 150 - 199 mg/dL whose physical examination findings and clinical laboratory findings other than triglyceride value do not deviate greatly from the normal values at the time of screening.
(3) Subjects who are available at every designated hospital visit.
(4) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.

Participant flow

screening
Selection
intake
Inspection

Adverse events

None

Outcome measures

safety

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 07 Day

Date of IRB

2017 Year 12 Month 14 Day

Anticipated trial start date

2018 Year 02 Month 14 Day

Last follow-up date

2018 Year 03 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 13 Day

Last modified on

2019 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035706


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name