UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039416 |
|---|---|
| Receipt number | R000044939 |
| Scientific Title | Effects of consumption of the proanthocianidins derived from Acacia Bark on blood pressure: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2020/02/06 |
| Last modified on | 2021/02/03 16:33:57 |
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Basic information
Public title
Effects of consumption of the test food on blood pressure
Acronym
Effects of consumption of the test food on blood pressure
Scientific Title
Effects of consumption of the proanthocianidins derived from Acacia Bark on blood pressure: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Effects of consumption of the proanthocianidins derived from Acacia Bark on blood pressure
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of 12-week-consumption of the test food on improving blood circulation and blood pressure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of sitting systolic blood pressure (SSBP) at 12 weeks after the start of test-food consumption (12w)
Key secondary outcomes
1. The ratio of the number of subjects who are less than 130 mmHg in SSBP and no more than 89 mmHg in sitting diastolic blood pressure (SDBP) at 12w
2. The measured values of SSBP at eight weeks after the start of test-food consumption (8w)
3. The measured values of SSBP at four weeks after the start of test-food consumption (4w)
4. The measured values of SSBP at the examination before test-food consumption (0w)
5. The change values of SSBP between at 0w and at 4w, 8w and 12w
6. The measured values of SDBP at 0w, 4w, 8w and 12w
7. The change values of SDBP between at 0w and at 4w, 8w and 12w
8. The measured value of superoxide dismutase (SOD) before cold water load and 30 min after cold water load at 0w, and the measured difference value* of SOD between before and 30 min after cold water load at 0w
9. The measured values of SOD before and 30 min after cold water load at 12w, and the measured difference value* of SOD between before and 30 min after cold water load at 12w
10. The change values of SOD before and 30 min after cold water load between at 0w and 12w, and the change difference value* of SOD between before and 30 min after cold water load between at 0w and 12w
11. The measured values of blood flow before and 30 min after cold water load at 0w and the measured difference value* of blood flow between before and 30 min after cold water load at 0w
12. The measured and change values of blood flow before and 30 min after cold water load at 12w and the measured difference value* of blood flow between before and 30 min after cold water load at 12w
13. The change values of blood flow before and 30 min after cold water load between at 0w and 12w and the measured difference value* of blood flow between before and 30 min after cold water load between at 0w and 12w
*8-13 difference value = the value of blood flow at 30 min after cold water load - the value of blood flow before cold water load
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Tablet containing proanthocianidins derived from Acacia Bark
Administration:
1. During test-food consumption: Take six tablets with water without chewing before meals.
* If you forget to take the test food, take it as soon as you remember within the day.
2. At the examination before test-food consumption: Take six tablets with water without chewing 60 minutes before cold water load.
Interventions/Control_2
Duration: 12 weeks
Test food: Placebo tablet
Administration:
1. During test-food consumption: Take six tablets with water without chewing before meals.
* If you forget to take the test food, take it as soon as you remember within the day.
2. At the examination before test-food consumption: Take six tablets with water without chewing 60 minutes before cold water load.
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. Healthy Japanese adult subjects
2. Subjects who have relatively high levels of blood pressure, or being anxious about or suffering their blood pressure
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects who are no more than 89 mmHg in diastolic blood pressure at screening (before test-food consumption)
5. Subjects who are between 130 mmHg or more and 139 mmHg or less in systolic blood pressure at screening (before test-food consumption)
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have severe anemia
5. Subjects who have or are suspected of secondary hypertension
6. Subjects who drink alcoholic beverages or smoke cigars immoderately
7. Subjects who work late-night shift or are irregular of their life-styles
8. Subjects who have vigorous exercise habits
9. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
10. Currently taking medicines (include herbal medicines) and supplements
11. Subjects who are allergic to medicines and/or the test food related products
12. Subjects who are pregnant, breast-feeding, and planning to become pregnant
13. 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 participate another trial during this trial
14. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Acacia-No-Ki Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 06 | 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
66
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
| 2020 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 06 | Day |
Last modified on
| 2021 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044939
