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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019315
Receipt No. R000022334
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
Date of disclosure of the study information 2015/10/13
Last modified on 2016/05/10

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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
Middle name
Last name Kakei Ryu
Organization Showa University
Division name Clinical Research Institute for Clinical Pharmacology and Therapeutics
Zip code
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
Middle name
Last name Naoki Uchida MD, PhD
Organization Showa University School of Medicine
Division name Department of Clinical Pharmacology
Zip code
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
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 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
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
Anticipated trial start date
2015 Year 11 Month 15 Day
Last follow-up date
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
2016 Year 05 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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