UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019315 |
|---|---|
| Receipt number | 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 | 2020/12/25 16:43:42 |
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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 | 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
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
nuchida@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine Department of Clinical Pharmacology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022334
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