UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055184 |
|---|---|
| Receipt number | R000062996 |
| Scientific Title | The Effect of Coffee-derived Mannooligosaccharides on the Intestinal Condition in Healthy Adults -A Systematic Review with Meta-analysis-(updated version from 2017 publication):Protocol |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/12/09 13:47:06 |
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Basic information
Public title
The Effect of Coffee-derived Mannooligosaccharides on the Intestinal Condition in Healthy Adults
-A Systematic Review with Meta-analysis-(updated version from 2017 publication):Protocol
Acronym
The Effect of Coffee-derived Mannooligosaccharides on the Intestinal Condition in Healthy Adults
-A Systematic Review with Meta-analysis-(updated version from 2017 publication):Protocol
Scientific Title
The Effect of Coffee-derived Mannooligosaccharides on the Intestinal Condition in Healthy Adults
-A Systematic Review with Meta-analysis-(updated version from 2017 publication):Protocol
Scientific Title:Acronym
The Effect of Coffee-derived Mannooligosaccharides on the Intestinal Condition in Healthy Adults
-A Systematic Review with Meta-analysis-(updated version from 2017 publication):Protocol
Region
| Japan |
Condition
Condition
The subjects are healthy volunteers (excluding those under 20, pregnant women, and lactating women, who were not suffering from any diseases) or ones with a tendency for constipation.Studies that are relevant to the outcome in question and include participants being treated as patients will be excluded.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine whether the consumption of food containing 'coffee-derived mannooligosaccharides' has a bowel regulating effect on healthy adults and people who are not ill but prone to constipation compared to the consumption of placebo food, specifically whether it improves the number of days/week of defecation, number of defecations/week, number of bifidobacteria in the stool and bifidobacterial occupancy rate.
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
Key secondary outcomes is defecation amount per week.
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
P-Participant:The subjects are healthy volunteers (excluding those under 20, pregnant women, and lactating women, who were not suffering from any diseases) or ones with a tendency for constipation.Studies that are relevant to the outcome in question and include participants being treated as patients will be excluded.
I-Intervention:The intervention condition is oral intake of a test product containing at least 1 g of 'coffee-derived mannooligosaccharides' (any form of intake) for a period of at least 2 weeks.
C-Comparison:A comparison was made among one receiving a placebo, another serving as a control group in which food was substituted with food that does not contain 'coffee-derived mannooligosaccharides' and group with no intervention.
O-Outcome measurement:
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 is defecation amount per week. Both are presented as means and standard deviations with respect to the amount of change.
S-Study design:The research designs used in the literature were randomized parallel group controlled trials, quasi-randomized controlled trials, non-randomized controlled trials, and crossover studies. In addition, the languages of presentation were documents written in Japanese and English. In principle, the form of presentation should be an original paper, but short reports and reports may be accepted if the content can be identified. To avoid publication bias, studies that include results published in clinical trial registration databases are also eligible. For the time period, studies published from the first time the databases were opened or loaded to the date of the search will be included in the search.
Key exclusion criteria
Abstracts of conference presentations (conference proceedings) will be excluded they are considered insufficiently descriptive. Other gray documents will be excluded it is difficult to confirm their appropriateness.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Kumaoh |
Organization
Ajinomoto AGF, INC.
Division name
Technology Development Dept. Technical Research and Development Institute
Zip code
210-8681
Address
1-1, Suzuki-cho Kawasaki-ku, Kawasaki-shi Kanagawa Pref.
TEL
044-223-4157
toshio.kumaoh.hv8@agf.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ishitani |
Organization
Ajinomoto AGF, INC.
Division name
Technology Development Dept. Technical Research and Development Institute
Zip code
2108681
Address
1-1, Suzuki-cho Kawasaki-ku, Kawasaki-shi Kanagawa Pref.
TEL
044-223-4157
Homepage URL
yuki.ishitani.4yu@agf.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
Review team
Dr. Shigeyoshi Fujii, Former employees of Ajinomoto AGF, Inc.
Research Collaborator
Professor Hiroharu Kamioka, Tokyo University of Agriculture
Holders of library librarian qualifications
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
044-223-4157
yuki.ishitani.4yu@agf.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
| 2025 | Year | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information sources
10 databases and research registries will be searched. The search targets studies published from the time the site was first established or installed up to the date of each search.
Selection process
Based on the eligibility criteria (PICOS), two research reviewers (SF and YI) will independently conduct a first screening (abstract confirmation level) and a second screening (full text level) of the articles; they will then cross-check them and decide in consultation, including TK, on any inconsistencies. If there are discrepancies, the decision will be made by HK, the research collaborator.
Risk of bias in individual studies
The risk of bias assessment of individual studies is carried out using a 13-item checklist arranged by SR expert HK based on the Cochrane Collaboration Programme Review Manual.
Data synthesis
For meta-analysis eligibility, meta-analyses will be conducted using Review Manager for studies with low or medium risk of bias and no heterogeneity in PICOS. Any missing data in each of the included studies will be excluded, but authors will be contacted and figures will be incorporated if known.
Meta-bias
Publication bias will be assessed by conducting a Funnel Plot. To avoid publication bias, multiple databases should be searched and author confirmation should be performed if deficiencies or uncertainties regarding study design or data are identified.
Indirectness
Indirectness is assessed by classifying all cases exceeding 80 as Low (0), 40 to 79 cases as Moderate/Suspicious (-1), and fewer than 40 cases as High (-2).
Imprecision
Imprecision is graded as precise (0) for a total of 80 or more cases, slightly imprecise (-1) for 40-79 cases and imprecise (-2) for less than 40 cases.
Inconsistency
Inconsistency is assessed by I2 values and tests of heterogeneity based on meta-analysis effect estimates.
Management information
Registered date
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062996
