UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057072 |
|---|---|
| Receipt number | R000065237 |
| Scientific Title | Evaluation of the efficacy of phytosterols supplementation on LDL cholesterol in participants with borderline high LDL cholesterol: A randomized, placebo-controlled, double-blind, parallel-group study |
| Date of disclosure of the study information | 2025/02/19 |
| Last modified on | 2025/08/28 09:58:30 |
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Basic information
Public title
Evaluation of the efficacy of phytosterols supplementation on LDL cholesterol in participants with borderline high LDL cholesterol
Acronym
Evaluation of the efficacy of phytosterols supplementation on LDL cholesterol in participants with borderline high LDL cholesterol
Scientific Title
Evaluation of the efficacy of phytosterols supplementation on LDL cholesterol in participants with borderline high LDL cholesterol: A randomized, placebo-controlled, double-blind, parallel-group study
Scientific Title:Acronym
Evaluation of the efficacy of phytosterols supplementation on LDL cholesterol in participants with borderline high LDL cholesterol: A randomized, placebo-controlled, double-blind, parallel-group study
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of phytosterols intake on LDL cholesterol in healthy Japanese men and women with borderline high LDL cholesterol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LDL cholesterol: 12 weeks after the start of intake
Key secondary outcomes
Efficacy
LDL Cholesterol: baseline, 4 and 8 weeks after the start of intake
HDL cholesterol, non-HDL cholesterol, total cholesterol, LDL/HDL ratio, triglyceride: baseline, 4, 8, and 12 weeks after the start of intake
Safety
Incidence of side effects and adverse events: 12 weeks after the start of intake
Physical examination, hematological examination, blood biochemistry test, urinalysis: baseline, 4, 8, and 12 weeks after the start of intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake period: 12 weeks
Test food: Hard capsules containing 800 mg vegetable sterol formulation (phytosterols content 400 mg/6 capsules )
Twice a day (6 capsules/day)
Interventions/Control_2
Intake period: 12 weeks
Test food: Placebo hard capsules
Twice a day (6 capsules/day)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese males and females between the ages of 20 and 65 years at the time of consent.
2. Participants with borderline high LDL cholesterol (120 mg/dL or more and less than 140 mg/dL).
3. Participants who have been fully informed of the purpose and content of this study and who have signed an informed consent form prior to the start of this study.
Key exclusion criteria
1. Those who are currently being treated for a serious illness.
2. Sitosterolemia.
3. Participants with food allergies or who may have an allergic reaction to the test food.
4. Those who regularly consume medicines or quasi-drugs that may affect the test items.
5. Those who regularly consume health foods (foods for specified health uses, foods with nutrient function claims, foods with functional claims, dietary supplements, etc.) that may affect the test items.
6. Those who are unable to discontinue the use of drugs(except for medication as needed), quasi-drugs, or health foods (foods for specified health uses, foods with nutrient function claims, foods with functional claims, dietary supplements, etc.) from the time of obtaining consent to the end of this study.
7. Those who work day and night shifts and those who plan to work multiple night shifts during this study.
8. Those whose normal alcohol consumption exceeds 20 g of alcohol equivalent per day.
9. Those whose normal smoking amount exceeds 20 cigarettes per day.
10.Those participating in other studies or who have participated in other studies within the past 3 months.
11.Those who intends to participate in other clinical studies during this study period.
12.Those who are unable to maintain their daily lifestyle (diet, exercise, smoking etc.).
13.Those who have difficulty consuming the test food as instructed.
14.Pregnant, lactating, or wishing to become pregnant.
15.Those determined by the principal investigator to be inappropriate in this study.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
Surgery
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Ryuto |
| Middle name | |
| Last name | Takahashi |
Organization
Riken Vitamin Co., Ltd.
Division name
Healthcare Unit
Zip code
160-0004
Address
1-6-1, Yotsuya, Shinjuku-ku, Tokyo, Japan
TEL
03-5362-1334
Homepage URL
ryu_takahashi@rike-vita.co.jp
Sponsor or person
Institute
Riken Vitamin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Riken Vitamin 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
Ethics Review Board of Medical Corporation Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
food-contact@apoplus.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 | 02 | Month | 19 | 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
0
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
Terminated
Date of protocol fixation
| 2025 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study has been cancelled before participants could enroll due to delays in preparing the test foods.
Management information
Registered date
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065237
