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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024229 |
Receipt No. | R000027816 |
Scientific Title | Effects of a Granule Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2017/04/03 |
Basic information | ||
Public title | Effects of a Granule Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure | |
Acronym | Effects of a Granule Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure | |
Scientific Title | Effects of a Granule Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure | |
Scientific Title:Acronym | Effects of a Granule Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure | |
Region |
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Condition | ||
Condition | Normal high blood pressure or Grade 1 hypertension | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study examine effect of a granule containing fermented soba extract (neo-FBS) on the decrease of blood pressure. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Blood pressure, pulsation (Week 0, Week 4, Week 8, Week 12) |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Oral ingestion of the test products containing fermented soba extract (2g per a day; 8 weeks) | |
Interventions/Control_2 | Oral ingestion of the test products containing fermented soba extract (2g per a day; 8 weeks) | |
Interventions/Control_3 | Oral ingestion of the placebo not containing fermented soba extract (2g per a day; 8 weeks) | |
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) Males and females aged 30-70 years
2) Individuals who are healthy and are not receiving treatment of disease 3) Individuals who are high normal blood pressure (SBP: 130-140mmHg and/or DBP: 85-90mmHg) and Grade 1 hypertension (SBP: 140-160mmHg and/or DBP: 90-100mmHg) 4) Individuals whose written informed consent has been obtained 5) Individuals judged appropriate for the study by the principal |
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Key exclusion criteria | 1) Individuals who are sensitive to a food containing soba and test product or other foods, and medical products
2) Individuals who are receiving treatment of serious hepatopathy, kidney damage, heart disease and hematological disease 3) Individuals who have a habit of smoking 4) Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period 5) Individuals who participated in other clinical studies in the past three months 6) Individuals who are or are possibly pregnant, or are lactating |
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Target sample size | 54 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | SBS Shizuoka Health Promotion Center | ||||||
Division name | Deputy Director | ||||||
Zip code | |||||||
Address | 3-1-1, Toro Shizuoka Suruga-ku, Shizuoka | ||||||
TEL | 054-282-1109 | ||||||
dokku@sbs-smc.or.jp |
Public contact | |||||||
Name of contact person |
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Organization | Laboratory of Cell Applied Technologies, Co | ||||||
Division name | Director | ||||||
Zip code | |||||||
Address | 2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8512 Japan | ||||||
TEL | 044-979-1622 | ||||||
Homepage URL | |||||||
info@l-cat.co.jp |
Sponsor | |
Institute | Laboratory of Cell Applied Technologies, Co |
Institute | |
Department |
Funding Source | |
Organization | Daiwa Pharmaceutical Co.,Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
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Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 trial data considered complete | |||||||
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=R000027816 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |