UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052269 |
|---|---|
| Receipt number | R000059665 |
| Scientific Title | Evaluation of the efficacy of phytosterols intake on changes in urinary symptoms in healthy middle-aged and elderly men: A randomized, placebo-controlled, double-blind, parallel-group study |
| Date of disclosure of the study information | 2023/09/22 |
| Last modified on | 2025/05/02 10:14:46 |
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Basic information
Public title
Evaluation of the efficacy of phytosterols intake on changes in urinary symptoms in healthy middle-aged and elderly men
Acronym
Evaluation of the efficacy of phytosterols intake on changes in urinary symptoms in healthy middle-aged and elderly men
Scientific Title
Evaluation of the efficacy of phytosterols intake on changes in urinary symptoms in healthy middle-aged and elderly men: A randomized, placebo-controlled, double-blind, parallel-group study
Scientific Title:Acronym
Evaluation of the efficacy of phytosterols intake on changes in urinary symptoms in healthy middle-aged and elderly men: 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 investigated the effects of phytosterols intake on urinary symptoms in healthy middle-aged and elderly Japanese men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IPSS: baseline and 26, 53 weeks after the start of intake
Key secondary outcomes
Efficacy
IPSS(QOL): baseline and 26, 53 weeks after the start of intake
urinary frequency: baseline and 26, 53 weeks after the start of intake
OABSS: baseline and 26, 53 weeks after the start of intake
postvoid residual urine volume: baseline and 26, 53 weeks after the start of intake
maximum urinary flow rate: baseline and 53 weeks after the start of intake
Safety
expression rate of side effects and adverse events: 53 weeks after the start of intake
physical examination, hematological examination, blood biochemistry test, urinalysis: baseline and 26, 53 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: 53 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: 53 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
| 55 | years-old | <= |
Age-upper limit
| 79 | years-old | > |
Gender
Male
Key inclusion criteria
1. Japanese.
2. Healthy adult males.
3. Participants who are judged as eligible to participate in the study by the principal investigator.
4. PSA-HS is less than 4 ng/mL.
5. OABSS-urgency score is less than 2 or OABSS total score is less than 3.
6. Prostate volume is less than 30 mL.
7. Maximum urinary flow rate is 15 mL/s or more and postvoid residual urine volume is less than 50 mL.
8. Daytime urinary average frequency is 8 or more and less than 15.
9. Participants who have been fully informed of the purpose and content of this study and who have signed a consent form prior to the start of this study.
Key exclusion criteria
1. Undergoing treatment for or having history of malignancy, heart failure, or myocardial infarction.
2. With implanted pacemaker or implantable cardioverter defibrillator.
3. Undergoing treatment for arrhythmia, liver disease, kidney injury, cerebrovascular disease, rheumatism, diabetes, or other chronic disease.
4. Those who scheduled to undergo surgery during or within 2 weeks after the intake period.
5. Undergoing treatment or had been treated within 2 months for benign prostatic hyperplasia, prostatitis, prostate cancer, overactive bladder, underactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stenosis, neuropathy, polyuria, or nycturia.
6. Sitosterolemia.
7. Those who wake up more than twice at bedtime to urinate.
8. Overactive bladder symptom.
9. IPSS total score is 8 or more.
10. Those who constantly consume alcohol exceeding the appropriate amount.
11. Those who regularly consume foods or beverages that is possible to affect urination.
12. Those who regularly consume medicine, Chinese herbal medicines, or supplements that is possible to affect urination.
13. Those who have been taking medicine or supplements to lower cholesterol levels.
14. Participants with allergies to drugs or foods associated with the test food.
15. Those who have participated in other studies within a month prior to the consent, or planned participation during this study.
16. Those who are judged as unsuitable to participate in the study by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | SHIMIZU |
Organization
Medical corporation Seishukai Hasegawa Hospital
Division name
Director of the Hasegawa Hospital
Zip code
116-0014
Address
5-45-7 Higashinippori, Arakawa-ku, Tokyo, Japan
TEL
03-3807-8976
t-takahama@seishukai.or.jp
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
Medical Corporation Seishukai Seishukai Clinic Ethical Review Board
Address
3-18-5 Matsugaya, Taito-ku, Tokyo, Japan
Tel
03-5827-0930
k-sudo@seishukai.or.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
医療法人社団渡辺病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 22 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Revised the protocol due to changes in inclusion criteria and conditions (approved by the Ethical Review Board on October 27, 2023).
Management information
Registered date
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059665
