UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049614 |
|---|---|
| Receipt number | R000056503 |
| Scientific Title | A study to confirm the effect of mixed coffee with coffee oligosaccharide on defecation.-A randomized, double-blind,placebo-controlled, crossover comparative study - |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/12/04 10:53:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to confirm the effect of mixed coffee with coffee oligosaccharide on defecation.-A randomized, double-blind,placebo-controlled, crossover comparative study -
Acronym
A study to confirm the effect of mixed coffee with coffee oligosaccharide on defecation.
Scientific Title
A study to confirm the effect of mixed coffee with coffee oligosaccharide on defecation.-A randomized, double-blind,placebo-controlled, crossover comparative study -
Scientific Title:Acronym
A study to confirm the effect of mixed coffee with coffee oligosaccharide on defecation.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of instant coffee with coffee oligosaccharide on defecation for healthy adult males and females.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation survey
Key secondary outcomes
Intestinal flora
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
Intake of test food for 14 days -> Washout(14 days) -> Intake of placebo food for 14 days
Interventions/Control_2
Intake of placebo food for 14 days -> Washout(14 days) -> Intake of test food for 14 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females aged of 20-64 years.
2)Subjects who defecate 2~5 times from the screening test per week.
3)Subjects who can visit on schedule days.
4)Subjects who recognize the object and contents of the study and submit the written informed consent.
Key exclusion criteria
1)Subjects taking medicine laxatives or antibiotics.
2)Subjects unable to collect stool samples on the designated date.
3)Subjects taking pharmaceuticals (abortive medication is allowed).
4)Subjects with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease.
5)Subjects who regularly use health foods and supplements affecting the study.
6)Subjects who have allergy related to the test foods
7)Subjects who are shift workers or graveyard shift workers.
8)Subjects with extremely irregular daily habits and eating habits.
9)Subjects who usually intake heavy amount of alcohol (40g alcohol/day>=) and who are excessive smoker(21 cigarettes/day>=).
10)Subjects who have systolic blood pressure <90 mmHg.
11)Subjects who feel bad mood by blood collection.
12)Subjects who donated 200 mL or more of blood within 1 month from the screening test.
13)Subjects already participating in other clinical trials.
14)Possible pregnancy, pregnancy and lactation.
15)Subjects who are ineligible due to physician's judgment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Fukuhara |
Organization
Fukuhara Clinic
Division name
Hospital director
Zip code
061-1351
Address
3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido, Japan
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | Toyotada |
| Middle name | |
| Last name | Ashino |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
t-ashino@ndrcenter.co.jp
Sponsor or person
Institute
AJINOMOTO AGF, INC.
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO AGF, INC.
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
Fukuhara Clinic Clinical Trial Review Committee
Address
1-15, Shimamatsuhigashimachi-3-chome, Eniwa-shi, Hokkaido
Tel
0123-36-8029
d-kameda@mediffom.co.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 01 | 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
32
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
| 2022 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056503
