UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025016 |
|---|---|
| Receipt number | R000028763 |
| Scientific Title | The effect of coffee-derived mannooligosaccharides on the intestinal condition - A systematic review with meta-analysis |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2017/08/03 10:04:59 |
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Basic information
Public title
The effect of coffee-derived mannooligosaccharides on the intestinal condition - A systematic review with meta-analysis
Acronym
A systematic review of coffee-derived mannooligosaccharides
Scientific Title
The effect of coffee-derived mannooligosaccharides on the intestinal condition - A systematic review with meta-analysis
Scientific Title:Acronym
A systematic review of coffee-derived mannooligosaccharides
Region
| Japan |
Condition
Condition
Healthy adult volunteers or ones with a tendency for constipation
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this review is to evaluate the effect of coffee derived-mannooligosaccharides on the intestinal condition by performing a systematic review with meta-analysis of randomized controlled trials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures are defecation days/week, defecation frequency/week, fecal Bifidobacterium count and the occupancy rate of Bifidobacterium in the total fecal microbiota.
Key secondary outcomes
Defecation amount per week is a secondary outcome.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 and Female
Key inclusion criteria
Systematic literature search using scientific databases and registered databases for clinical trials and systematic review will be performed. Key inclusion criteria are as follows:
Participants: Healthy adults or adults with a tendency for constipation
Intervention: Intake for more than 2 weeks
Comparison: Placebo controll, in principle
Outcome: Regulation of intestinal condition(see above outcome column)
Study design: Adopt intervention study (Randomized parallel group comparison test, randomized cross over test, quasi-randomized parallel group comparison test, quasi-randomized cross over test, non-randomized parallel group comparison test)
Key exclusion criteria
We will exclude the literature which does not meet the key inclusion criteria.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeyoshi Fujii |
Organization
Ajinomoto General Foods, Inc.
Division name
Technical Research and Development
Zip code
Address
Sanken Building, 3-25-1, Hyakunin-cho Shinjuku-ku, Tokyo 169-0073 Japan
TEL
03-5338-6713
Shigeyoshi_Fujii@agf.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeyoshi Fujii |
Organization
Ajinomoto General Foods, Inc.
Division name
Technical Research and Development
Zip code
Address
Sanken Building, 3-25-1, Hyakunin-cho Shinjuku-ku, Tokyo 169-0073 Japan
TEL
03-5338-6713
Homepage URL
Shigeyoshi_Fujii@agf.co.jp
Sponsor or person
Institute
Ajinomoto General Foods, Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto General Foods, Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Review team
Mr. Kenji Yamamura, Technical Research & Development. Ajinomoto General Foods, Inc.
Ms. Kaho Kanatani, Technical Research & Development, Ajinomoto General Foods, Inc.
Research Collaborator
Professor Hiroharu Kamioka, Faculty of Regional Environment Science, Tokyo University of Agriculture
Dr. Takahiro Yoshizaki, Department of Nutritional Science, Department of Toyo University
Ms. Mari Makishi, Toho University Narashino Media Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.lifescience.co.jp/yk/yk17/july/ab1.html
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
| 2016 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search: We will systematically search scientific databases and registered databases for clinical trials and systematic review.
The search is performed by a specific searcher (hospital librarians, MM) who is qualified in medical information handling, and who is sophisticated in searches of clinical trials. Two authors will independently screen the literature based on key inclusion criteria.
Risk of bias (quality) assessment
Two authors will independently assess risk of bias based on GRADE. Agreement between the two review authors with regard to the primary outcomes and the risk of bias items will be reported as concordance rate and kappa coefficient. Indirectness, inconsistency and imprecision will be also assessed.
Meta-analysis: Meta-analysis for synthetic data using Review Manager(RevMan 5.2) will be performed by TY who is highly experienced in handling meta-analysis. Estimated effect size will be expressed as standardized mean difference and 95% CI will be also calculated using randomized effect model. Forest plot will be conducted and heterogeneity will be also assessed. Publication bias will be assessed by funnel plot.
Subgroup analysis: We will perform subgroup analysis for the intake amount of coffee-derived mannooligosaccharides and participants restricted to ones with a tendency for constipation. We will also conduct sub-group analysis using only randomized parallel-group trial. If the RCT includes extremely large sample size, this RCT will be excluded for the analysis.
Management information
Registered date
| 2016 | Year | 11 | Month | 28 | Day |
Last modified on
| 2017 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028763
