UMIN-CTR Clinical Trial

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

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Acacia-No-Ki Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2020

Year

02

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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