UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of coffee-derived mannooligosaccharides on the intestinal condition - A systematic review with meta-analysis
Title of the study (Brief title)	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	Shigeyoshi Fujii
Organization	Ajinomoto General Foods, Inc.
Division name	Technical Research and Development
Address	Sanken Building, 3-25-1, Hyakunin-cho Shinjuku-ku, Tokyo 169-0073 Japan
TEL	03-5338-6713
Email	Shigeyoshi_Fujii@agf.co.jp

Public contact
Name of contact person	Shigeyoshi Fujii
Organization	Ajinomoto General Foods, Inc.
Division name	Technical Research and Development
Address	Sanken Building, 3-25-1, Hyakunin-cho Shinjuku-ku, Tokyo 169-0073 Japan
TEL	03-5338-6713
Homepage URL
Email	Shigeyoshi_Fujii@agf.co.jp

Sponsor
Institute	Ajinomoto General Foods, Inc.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.lifescience.co.jp/yk/yk17/july/ab1.html
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028763