UMIN-CTR Clinical Trial

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

Healthy adult volunteers or ones with a tendency for constipation

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

Shigeyoshi_Fujii@agf.co.jp

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

Email

Shigeyoshi_Fujii@agf.co.jp

Institute

Ajinomoto General Foods, Inc.

Institute

Department

Personal name

Organization

Ajinomoto General Foods, Inc.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Published

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

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 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.

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