UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023184
Receipt number R000026727
Scientific Title Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure: a randomized, double-blind, placebo-controlled, parallel group comparison study
Date of disclosure of the study information 2016/07/15
Last modified on 2017/05/30 17:39:01

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Basic information

Public title

Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure: a randomized, double-blind, placebo-controlled, parallel group comparison study

Acronym

Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure

Scientific Title

Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure: a randomized, double-blind, placebo-controlled, parallel group comparison study

Scientific Title:Acronym

Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the clinical usefulness of 12-weeks ingestion of plum extract on the improvement of blood pressure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

systolic pressure and diastolic pressure at 4 weeks, 8 weeks and 12 weeks after the beginning of ingestion of test meals and at 2 weeks after the end of ingestion of test meals

Key secondary outcomes

peripheral blood flow, TC, HDL-C, LDL-C, TG, fasting plasma glucose, HbA1c, platelet aggregation, defecation frequency, VAS 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

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of the plum extract-processed food (30 g) daily for 12 weeks

Interventions/Control_2

Ingestion of the placebo food (30 g) daily for 12 weeks

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

30 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1. Subjects whose hospital SBP is >=130 mmHg and <160 mmHg.
2. Subjects who agree to participate in the current study with a written informed consent.

Key exclusion criteria

1. Subjects who are under treatment and medication for hypertension.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities.
3. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with unusually high and/or low blood pressure or abnormal hematological data
5. Subjects with serious anemia.
6. Pre- or post-menopausal subjects having complaints of obvious physical changes.
7. Subjects who are at risk of having allergic reactions to drugs or foods (especially plum, fruits of the family Rosacea and/or white birch pollen).
8. Subjects regularly take medicine, functional foods and/or supplements (peptide, acetic acid, GABA, geniposidic acid, flavonoids, sesamin, chlorella, olive leaves, garlics, dietary fiber, tomatoes, folic acid, long pepper extract, etc.) which would affect the blood pressure.
9. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
10. Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
11. Subjects who are pregnant or expected to be pregnant, or lactating during the study.
12. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial.
13. Any other medical reasons judged by the principal investigator.

Target sample size

72


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Department of Medical Management and Informatics

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4411

Email

nishihira@do-johodai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Center of Health Information Science

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4430

Homepage URL


Email

nishihira@do-johodai.ac.jp


Sponsor or person

Institute

Hokkaido Information University

Institute

Department

Personal name



Funding Source

Organization

NAKANO.B.C. 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


Email



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

北海道情報大学　保健センター（北海道）


Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 15 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


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

2016 Year 07 Month 05 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 28 Day

Last follow-up date

2016 Year 12 Month 10 Day

Date of closure to data entry

2017 Year 01 Month 25 Day

Date trial data considered complete

2017 Year 02 Month 01 Day

Date analysis concluded

2017 Year 04 Month 19 Day


Other

Other related information



Management information

Registered date

2016 Year 07 Month 15 Day

Last modified on

2017 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026727