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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028384 |
Receipt No. | R000032478 |
Scientific Title | A study to investigate effects of study food substance on lowering blood pressure: a verification study |
Date of disclosure of the study information | 2017/07/26 |
Last modified on | 2018/07/19 |
Basic information | ||
Public title | A study to investigate effects of study food substance on lowering blood pressure: a verification study | |
Acronym | A verification study to assess the effects of study food substance ingestion on lowering blood pressure. | |
Scientific Title | A study to investigate effects of study food substance on lowering blood pressure: a verification study | |
Scientific Title:Acronym | A verification study to assess the effects of study food substance ingestion on lowering blood pressure. | |
Region |
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Condition | |||
Condition | High-normal blood pressure and Grade 1 hypertension patients | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to evaluate the effect of healthy drink single ingestion on reducing blood pressure in high-normal blood pressure and grade 1 hypertension adult. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Systolic blood pressure and diastolic blood pressure |
Key secondary outcomes | Subjective evaluation questionnaire |
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 | |
Concealment | No need to know |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Single ingestion of study food substance (including involved raw materials 45g). | |
Interventions/Control_2 | Single ingestion of study food substance (including involved raw materials 90g). | |
Interventions/Control_3 | Single ingestion of control food substance. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Subjects with high normal blood pressure (systolic BP from 130 to 139, or diastolic BP from 85 to 89 mm Hg) and grade 1 hypertension (systolic BP from 140 to 159, or diastolic BP from 90 to 99 mm Hg)
2) BMI more than 18.5 kg/m2 but less than 30 kg/m2 2) Subjects who give consent in writing |
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Key exclusion criteria | 1) Subjects who have serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, metabolic system,
(2) Subjects who are under medication on a steady basis or history of medication for serious disorders (3) Subjects who are under treatment at healthcare facility for digestive system that effects on this study or have history of operation on digestive system (except appendectomy) 4) Subjects who have history of intolerance to study food substance 5) Subject with allergy to fruit 6) Subjects who are in pregnancy, lactation, or who are willing to become pregnant 7) Subjects who participated in other drug or food study within 1 month 8) Heavy smoker (20 or more/day) and heavy drinker (converted to alcohol 30g or more/day), or subjects with irregular lifestyle (9) Subjects who are ineligible due to physician's judgment based on background of subject, physical finding, interview |
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Target sample size | 24 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Medical Corporation Chisei-kai Tokyo Center Clinic | ||||||
Division name | Medical Corporation Chisei-kai Tokyo Center Clinic | ||||||
Zip code | |||||||
Address | Yaesu KT Bldg 1-1-8 Yaesu, Chuo-ku, Tokyo | ||||||
TEL | 03-3276-6935 | ||||||
miyake@tc-clinic.jp |
Public contact | |||||||
Name of contact person |
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Organization | CROee.INC | ||||||
Division name | Evidence Division | ||||||
Zip code | |||||||
Address | 2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan | ||||||
TEL | 03-5953-2108 | ||||||
Homepage URL | |||||||
imai@croee.com |
Sponsor | |
Institute | CROee.INC |
Institute | |
Department |
Funding Source | |
Organization | euglena 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 | |
Address | |
Tel | |
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 | 東京センタークリニック(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032478 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |