UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058160 |
|---|---|
| Receipt number | R000066379 |
| Scientific Title | A Systematic Review of the Effects of Gluconic Acid on Intestinal environment |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/12 11:36:52 |
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Basic information
Public title
A Systematic Review of the Effects of Gluconic Acid on Intestinal environment
Acronym
A Systematic Review of the Effects of Gluconic Acid on Intestinal environment
Scientific Title
A Systematic Review of the Effects of Gluconic Acid on Intestinal environment
Scientific Title:Acronym
A Systematic Review of the Effects of Gluconic Acid on Intestinal environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to evaluate whether the consumption of gluconic acid (I) improves the gut environment (O) in healthy adult men and women (P), compared to a placebo (C)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel movement frequency,Number of days with bowel movements,Fecal output,Fecal bacterial count,Putrefactive compounds
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Participants
(P): Healthy adult men and women. Individuals with any disease, minors, pregnant women, and lactating women were excluded.
Intervention
(I): Oral intake of processed foods containing gluconic acid. Studies were excluded if the amount of gluconic acid contained was not clearly specified.
Comparison
(C): Oral intake of processed foods that do not contain gluconic acid. In principle, studies were excluded if the placebo contained gluconic acid or other components known to affect the outcomes.
Outcome
(O): Improvement in the gut environment. Evaluation indicators included bowel movements, gut microbiota composition, and levels of putrefactive metabolites.
Key exclusion criteria
Exclude trials that do not meet the selection criteria, such as those including individuals with diseases.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Takeuchi |
Organization
Association of Japan CAM
Division name
N/A
Zip code
1510053
Address
#306 Onogibiru,3-46-16 Yoyogi, Shibuya-ku, Tokyo
TEL
0364574911
info@ajcam.biz
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N/A
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Otafuku Sauce Co., Ltd.
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
Japan Clinical Trial Association
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574666
info@yakujihou.org
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 | 06 | Month | 20 | 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
| 2025 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search Strategy
For database searches in PubMed, JDream3, UMIN, and ClinicalTrials.gov, reviewers A and B will discuss and set the search formulas corresponding to the research question and PICOS. The search formulas will combine thesaurus terms and free words in the databases. For the trial design filter, the "sensitivity and precision-maximizing version" from the Cochrane library will be used. Additionally, using the Consumer Affairs Agency's notification information search, studies adopted in the research review will be extracted from cases where gluconic acid were applied as functional ingredients.
Bias Risk Assessment
Evaluate selection bias (randomization, allocation concealment), blinding bias (participants, outcome assessors), attrition bias (analysis methods, incomplete outcome data), selective outcome reporting, other biases, summary, and non-directness of individual studies. Assess the risk as "high," "medium/suspected," or "low."
Certainty Assessment
Evaluate the risk of bias, indirectness, imprecision, inconsistency, and other factors (such as publication bias) for each outcome. Finally, these evaluations will be combined to assess the overall certainty of the evidence. The risk of bias, indirectness, imprecision, inconsistency, and other factors (such as publication bias) will be assessed in three levels: not serious, serious, and very serious. Certainty will be graded in four levels: A (strong), B (moderate), C (weak), and D (very weak).
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066379
