UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057692 |
|---|---|
| Receipt number | R000065829 |
| Scientific Title | Systematic Review on the Functional Effects of Salacinol Derived from Salacia in Suppressing Postprandial Blood Glucose Elevation |
| Date of disclosure of the study information | 2025/04/23 |
| Last modified on | 2025/04/23 09:55:48 |
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Basic information
Public title
Systematic Review on the Functional Effects of Salacinol Derived from Salacia in Suppressing Postprandial Blood Glucose Elevation
Acronym
Systematic Review on Postprandial Blood Glucose Related to Salacinol Derived from Salacia
Scientific Title
Systematic Review on the Functional Effects of Salacinol Derived from Salacia in Suppressing Postprandial Blood Glucose Elevation
Scientific Title:Acronym
Systematic Review on Postprandial Blood Glucose Related to Salacinol Derived from Salacia
Region
| Japan |
Condition
Condition
Healthy adults with normal or borderline fasting blood glucose levels (<126 mg/dL)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim was to investigate whether a single intake of Salacinol derived from Salacia suppresses the rise in postprandial blood glucose levels compared to placebo intake in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial blood glucose (30, 60, 90 and 120 minutes, AUC)
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 and Female
Key inclusion criteria
Participants P: Healthy adults with fasting blood glucose levels in the normal or borderline range (below 126 mg/dL).
Intervention I: A single oral intake of processed food containing Salacinol derived from Salacia. Limited to products based on Salacia reticulata with specified or clearly stated Salacinol content.
Placebo C: A single intake of processed food not containing Salacinol derived from Salacia. Excludes products containing Salacinol or other components known to affect outcomes, unless the content is minimal and deemed not to influence the outcome.
Outcome O: Suppression of postprandial blood glucose elevation. Blood glucose levels measured at 30, 60, 90, and 120 minutes after intake, and their AUC.
Study Types S: Randomized controlled trials (RCTs), randomized crossover trials, quasi-randomized controlled trials, and non-RCTs. Included studies must be original articles written in English or Japanese. Short reports and articles are included only if the study content can be identified. Conference proceedings are excluded. No restrictions on the search period. Studies meeting the above criteria are grouped together without further categorization.
Key exclusion criteria
Trials that do not meet the selection criteria, such as those including patients with fasting blood glucose levels of 126 mg/dL or higher, will be excluded.
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
151-0053
Address
#306 Onogibiru,3-46-16 Yoyogi, Shibuya-ku, Tokyo
TEL
03-6457-4911
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
KOEI KOGYO 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 | 04 | Month | 23 | 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 | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 24 | 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, JDream, UMIN, and ClinicalTrials.gov, reviewers A and B will discuss and set search formulas corresponding to the research question and PICOS. The search formulas will combine thesaurus terms and free words from the databases. For trial design filters, the "sensitivity- and precision-maximizing version" from the Cochrane library will be used. Additionally, the Consumer Affairs Agency's notification information search will be used to extract studies included in the research review from cases where Salacinol derived from Salacia was applied as a functional ingredient.
Bias Risk Assessment
Assessment will be conducted for 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. Risk will be evaluated as "high", "medium/suspected", or "low".
Certainty Assessment
For each outcome, bias risk, non-directness, imprecision, inconsistency, and other factors (such as publication bias) will be evaluated, and these will be collectively assessed to determine the overall certainty of the evidence. Bias risk, indirectness, imprecision, inconsistency, and other factors (such as publication bias) will be evaluated in three stages: 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 | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065829
