UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the function of intestinal regulation to subjects having tendency toward constipation. -Randomised double-blind placebo-controlled trial
Acronym	A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the function of intestinal regulation to subjects having tendency toward constipation. -Randomised double-blind placebo-controlled trial
Scientific Title	A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the function of intestinal regulation to subjects having tendency toward constipation. -Randomised double-blind placebo-controlled trial
Scientific Title:Acronym	A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the function of intestinal regulation to subjects having tendency toward constipation. -Randomised double-blind placebo-controlled trial
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of soft drink containing reduced type of indigestible dextrin on the function of intestinal regulation to subjects having tendency toward constipation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency per day, Defecation frequency per week, Fecal amount. Time of assessment: after two-week intake of active/placebo drinks, defecation frequency, defecation frequency and fecal amount are assessed on a weekly basis.
Key secondary outcomes	Fecal shape, color and odor. Feeling after defecation

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Prevention
Type of intervention	Food
Interventions/Control_1	Soft drink containing reduced type of indigestible dextrin(5g/serving) (2 weeks), washout(2 weeks), Placebo drink(2 weeks)
Interventions/Control_2	Placebo drink(2 weeks), washout(2 weeks), Soft drink containing reduced type of indigestible dextrin(5g/serving)(2 weeks)
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) (Healthy) subjects aged 20 to 59 years old (2) Subjects having meal 3 times per day (3) Subjects giving written informed consent
Key exclusion criteria	(1) Individuals taking antiflatulents and/or laxatives(including purgative drugs) in common use (2) Individuals taking health foods in common use, including food for specified health use, which influence intestinal regulation at the point of screening examination (3) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use at the point of screening examination (4) Individuals daily consuming alcohol as equivalent amount of sake more than 360ml (5) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use, which influence intestinal regulation during the study period (6) Individuals presenting known food allergy (7) Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications (8) Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (9) Individuals who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire (10) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (11) Individuals who are under treatment or have a history of drug/alcohol dependence (12) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (13) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code
Address	13-4 Kodenmacho, Nihonbashi, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshika Komori
Organization	KSO Corporation
Division name	Sales department
Zip code
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Coca-Cola(Japan) 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
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	2016 Year 04 Month 02 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	2016 Year 03 Month 01 Day
Date of IRB	2016 Year 03 Month 14 Day
Anticipated trial start date	2016 Year 04 Month 04 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 29 Day
Last modified on	2022 Year 06 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024980