UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000031272
Receipt No. 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 (Ver. 5)

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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
Institute Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035706