UMIN-CTR Clinical Trial

Basic information
Public title	The crossover study to investigate the effects of the 30% of carrot puree containing drink compared to 0% of the drink on the mean colonic transit time in healthy male subjects
Acronym	The Effects of carrot puree containing drink on the mean colonic transit time
Scientific Title	The crossover study to investigate the effects of the 30% of carrot puree containing drink compared to 0% of the drink on the mean colonic transit time in healthy male subjects
Scientific Title:Acronym	The Effects of carrot puree containing drink on the mean colonic transit time
Region	Japan

Condition
Condition	Healthy male adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effects of the 30% of carrot puree containing drink on the mean colonic transit time compared to 0% of the drink (as a placebo) in healthy male. The study is conducted by double blinded 2 period crossover design with 2 weeks washout periods in 2 groups, previous 30% of carrot puree containing drink ingestion group and 0% of the drink ingestion group. Subjects were randomly allocated to these two groups. The primary and secondary endpoints of the study are the mean total colonic transit time and the mean segmental transit time after 4 days study drink ingestion.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean total colonic transit time
Key secondary outcomes	Mean left colonic transit time Mean right colonic transit time Mean rectum transit time Mean Rectosigmoid colonic transit time Condition of stool defecation Output volume Frequency Color Smell Stool property (Bristol scale) Feeling after defecation Frequency of fart Safety

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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	30 % of Carrot puree containing drink 200mL twice a day(10am, 12pm), 7 days 2 weeks washout 0 % of Carrot puree containing drink (as a placebo) 200mL twice a day(10am, 12pm), 7 days
Interventions/Control_2	0 % of Carrot puree containing drink (as a placebo) 200mL twice a day(10am, 12pm), 7 days 2 weeks washout 30 % of Carrot puree containing drink (as a placebo) 200mL twice a day(10am, 12pm), 7 days
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	Not applicable
Gender	Male
Key inclusion criteria	1) Subjects who are not suffering from a chronic constipation (number of stool is more than 5 times/ week) 2) Subjects who are competent to consent. 3) Subjects who are competent to keep the rules of the study and are able to report self-condition. 4) Subjects who are judged eligible by the investigator in several series of medical interview conducted prior to study.
Key exclusion criteria	1) Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc). 2) Any history for allergy against any components in trial food. 3) Subjects who have a current and/or past clinical history which would occur an obstruction in GI tract. 4) Subjects who are daily taking any foods which will effect on bowel movement (incl. Functional display food, Food for specified health use, Supplements and so on) 5) Subjects who are inadequate for enrollment judged by the investigator.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Kakei Middle name Last name Ryu
Organization	Showa University
Division name	Clinical Research Institute for Clinical Pharmacology and Therapeutics
Zip code	157-8577
Address	6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577
TEL	03-3300-5247
Email	ryu-k@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Uchida Middle name Last name Naoki
Organization	Showa University School of Medicine
Division name	Department of Clinical Pharmacology
Zip code	157-8577
Address	6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577
TEL	03-3300-5254
Homepage URL
Email	nuchida@med.showa-u.ac.jp

Sponsor
Institute	Showa University School of Medicine Department of Clinical Pharmacology
Institute
Department

Funding Source
Organization	Tokyo Research center of clinical pharmacology
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	lnstitutional Review Board of ShowaUniversity Karasuyama Hospital
Address	6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo,157-8577 Japan
Tel	03-3300-5247
Email	scri@ofc.showa-u.ac.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	昭和大学臨床薬理研究所

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 13 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	26
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	2015 Year 10 Month 13 Day
Date of IRB	2015 Year 11 Month 16 Day
Anticipated trial start date	2015 Year 11 Month 16 Day
Last follow-up date	2016 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 12 Day
Last modified on	2020 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022334