UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049362 |
|---|---|
| Receipt number | R000056215 |
| Scientific Title | A verification study for blood pressure lowering effects of lemon juice; non-randomized, open, uncontrolled, single arm trial |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2024/02/13 13:56:21 |
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Basic information
Public title
A verification study for blood pressure lowering effects of lemon juice.; non-randomized, open, uncontrolled, single arm trial
Acronym
A verification study for blood pressure lowering effects of lemon juice
Scientific Title
A verification study for blood pressure lowering effects of lemon juice; non-randomized, open, uncontrolled, single arm trial
Scientific Title:Acronym
A verification study for blood pressure lowering effects of lemon juice
Region
| Japan |
Condition
Condition
Healthy subjects or hypertension
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of lemon juice on blood pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the blood pressure
Key secondary outcomes
Change of the pulse
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take the test sample (lemon juice) 30ml once a day
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, Subjects whose systolic blood pressure is 120 mmHg or more and less than 160 mmHg at screening
2, Subjects whose diastolic blood pressure is 80mmHg or more and less than 100 mmHg at screening
Key exclusion criteria
1.Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, serious heart disease and atrial fibrillation
2.Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3.Subjects whose systolic blood pressure is 160 mmHg or more and less than 120mmHg, and subjects whose diastolic blood pressure is 100mmHg or more and less than 80 mmHg
4, Subjects who have severe anemia
5, Subjects who have or are suspected to have secondary hypertension
6, Subjects who drink alcoholic beverages excessively or smoke cigars immoderately
7, Subjects with irregular work hors (e.g. shift workers)
8, Subjects who have vigorous exercise habits
9, Subjects who are allergic to citrus fruits
10, Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", in daily
11, Subjects who are currently taking antihypertensive medications
12, Subjects who are allergic to medicines and/or the test food related products
13, Subjects who are pregnant, lactating, or planning to become pregnant
14, Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period
15, Subjects who are inteligible to participate in the study based on the evaluation of the principal physician
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Inoue |
Organization
POKKA SAPPORO Food & Beverage Ltd.
Division name
Fundamental Research and Development institute
Zip code
425-0013
Address
10 Okatohme, Yaizu-city, Shizuoka,425-0013 JAPAN
TEL
054-629-7982
Takashi.inoue@pokkasapporo-fb.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Hiramitsu |
Organization
POKKA SAPPORO Food & Beverage Ltd.
Division name
Fundamental Research and Development institute
Zip code
425-0013
Address
10 Okatohme, Yaizu-city, Shizuoka,425-0013 JAPAN
TEL
054-629-7982
Homepage URL
masanori.hiramitsu@pokkasapporo-fb.co.jp
Sponsor or person
Institute
POKKA SAPPORO Food & Beverage Ltd.
Institute
Department
Personal name
Funding Source
Organization
POKKA SAPPORO Food & Beverage Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuoka University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of POKKA SAPPORO Food & Beverage Ltd.
Address
4-20-1 Ebisu, Shibuya-ku, Tokyo, 150-8522 JAPAN
Tel
03-5795-1105
Toshihiro.Takahashi@pokkasapporo-fb.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
| 2022 | Year | 10 | Month | 31 | 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
23
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 27 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056215
