UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation
Title of the study (Brief title)	Effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	bowel movements (frequency, volume, condition) in the ingestion period
Key secondary outcomes	flora, organic acid, putrefactive products, IgA in feces

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	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake OMF-01 for 2 weeks , washout for 2 weeks , Intake Dextrin powder for 2 weeks
Interventions/Control_2	Intake Dextrin powder for 2 weeks , washout for 2 weeks , Intake OMF-01 for 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	40 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1)Subjects with male: age 40 to 70, female: after menopause 2)Subjects with a tendency for constipation(2-4 times / week) 3)Healthy Subjects with no-treatment 4)Obtaining informed consent and signed a consent form
Key exclusion criteria	1) Subjects with a serious liver, kidney, heart damege, diabetes, food allergies, digestive disorder, suffering other serious diseases 2) Subjects having medical history or operation history of digestive disorder 3) Subjects cannot keep the lifestyle 4) Subjects cannot regularly have three meals a day 5)Shifts workers or Late-night workers 6) Subjects whose amount of dietary intake or exercise has changed significantly 7) Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 8) Subjects who take any kind of medicine and/or food for specified health uses and/or supplements and/or diet foods 9) Subjects with drug and food allergies 10) Subjects with a hypersensitivity reaction to test food (eczema, nausea, diarrhea, etc.) 11) Subjects cannot ingest the test food as directed 12) Subjects who usually drink more than 500ml of beer in terms of per day 13) Subjects who take dietary fiber, fermented foods, foods containing a lot of lactic acid bacteria or bifidobacteria or oligosacccharide 14) Subjects who smoked more than 20 average daily 15) Subjects cannot wright a life diary everyday 16) Subjects who participate other clinical trials or investigates in this trial 17) Subjects who are judged not applicable to this study by representative investigator or investigator
Target sample size	25

Research contact person
Name of lead principal investigator	Tohru Nishiyama
Organization	Fuefuki Central Hospital
Division name	Assistant Director
Address	47-1, Isawachoyokkaichiba, Fuefuki, Yamanashi, Japan
TEL	055-262-2185
Email	fuefukihp@fch.or.jp

Public contact
Name of contact person	Natsumi Oka
Organization	QOL RD Co.,Ltd.
Division name	CRO Department Food Division
Address	2-14-1,Nihonbashi,Chuo-Ku,Tokyo, Japan
TEL	03-6386-8809
Homepage URL
Email	n-oka@qol-rd.co.jp

Sponsor
Institute	QOL RD Co.,Ltd.
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	笛吹中央病院（山梨県）、みずの内科クリニック（埼玉県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 18 Day
Anticipated trial start date	2016 Year 05 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 10 Day
Last modified on	2017 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025649