UMIN-CTR Clinical Trial

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
Email	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
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044939