UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059394 |
|---|---|
| Receipt number | R000067931 |
| Scientific Title | Improving effects on blood lipids of Cuban sugarcane derived policosanol by oral administration: A systemic review and meta-analysis |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/10/14 16:16:22 |
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Basic information
Public title
Improving effects on blood lipids of Cuban sugarcane derived policosanol by oral administration: A systemic review and meta-analysis
Acronym
Improving effects on blood lipids of Cuban sugarcane derived policosanol: A systemic review and meta-analysis
Scientific Title
Improving effects on blood lipids of Cuban sugarcane derived policosanol by oral administration: A systemic review and meta-analysis
Scientific Title:Acronym
Improving effects on blood lipids of Cuban sugarcane derived policosanol: A systemic review and meta-analysis
Region
| Japan |
Condition
Condition
Healthy adults with blood LDL cholesterol less than 140 mg/dL
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the improving effects on blood lipids of Cuban sugarcane derived policosanol by consecutive oral administration in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood lipid parameters(LDL-C, TC, HDL-C, LDL-C/HDL-C ratio, TG)
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
PICOS:
Participant: Healthy adults with LDL-C<140mg/dL
Intervention: Consecutive oral intake of Cuban sugarcane derived policosanol
Comparison: Consecutive oral intake of Cuban sugarcane derived placebo
Outcome: Blood lipid parameters(LDL-C, TC, HDL-C, LDL-C/HDL-C ratio, TG)
Study design: Randomized placebo controlled trials (RCT), quasi-randomized placebo controlled trials (qRCT)
Key exclusion criteria
1. Those that do not use blood LDL-C, TC, HDL-C, or TG as indicators
2. Those not derived from Cuban sugarcane-based policosanol
3. Those with an unknown amount of Cuban sugarcane-derived policosanol
4. Those combined with other ingredients (excluding those the other ingredients are shared with the placebo)
5. Those in which PICO cannot be assessed
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Uehara |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
8140180
Address
8-19-1 Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka
TEL
092-871-6631
ueharay@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinari |
| Middle name | |
| Last name | Uehara |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
8140180
Address
8-19-1 Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka
TEL
092-871-6631
Homepage URL
ueharay@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Raydel Japan Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable for the systematic review and meta-analysis
Address
N/A
Tel
092-871-6631
ueharay@fukuoka-u.ac.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 | 10 | Month | 16 | 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 | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research review will be conducted in accordance with PRISMA2020
Management information
Registered date
| 2025 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067931
