UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025973
Receipt number R000029856
Scientific Title Effect of nuoc mam supplements on human
Date of disclosure of the study information 2018/05/02
Last modified on 2018/07/09 13:49:18

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Basic information

Public title

Effect of nuoc mam supplements on human

Acronym

nuoc mam clinical trial

Scientific Title

Effect of nuoc mam supplements on human

Scientific Title:Acronym

nuoc mam clinical trial

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of supplements containing fermented nuoc mam on Blood pressure of healthy Japanese

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Blood pressure

Key secondary outcomes

Biochemical analyses


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

Prevention

Type of intervention

Food

Interventions/Control_1

Nuoc mam supplements
3 capsule/day

Interventions/Control_2

Placebo supplements
3 capsule/day

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) persons who is generally judged as healthy
(2) persons who feel change in their body shapes and blood presure/or disturbance of the life
(3) Persons who can give voluntary written consent to participate in the present trial

Key exclusion criteria

(1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2) persons who have changed their habitats to take supplements within past 4 weeks.
(3) Persons who work in night shift or in day and night shift
(4) persons who have been treated their illness or prevention in a clinic at their informed consent
(5) persons with their medical histories as follows: serious diseases of sugar metabolism,lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6) persons with the medical histories of alcoholism or drug dependence
(7) persons who might be developed allergic reaction to foods.
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10) persons who will not be judged suitable to the participants by the investigator.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kuniyoshi Shimizu

Organization

Faculty of Agriculture, Kyushu University

Division name

Laboratory of Systematic Forest and Forest Products Science

Zip code


Address

6-10-1 Hakozaki, Higashi-ku, Fukuoka, Fukuoka, JAPAN

TEL

092-642-3002

Email

shimizu@agr.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kuniyoshi Shimizu

Organization

Faculty of Agriculture, Kyushu University

Division name

Laboratory of Systematic Forest and Forest Products Science

Zip code


Address

6-10-1 Hakozaki, Higashi-ku, Fukuoka, Fukuoka, JAPAN

TEL

092-642-3002

Homepage URL


Email

shimizu@agr.kyushu-u.ac.jp


Sponsor or person

Institute

Faculty of Agriculture, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Yazuya Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Faculty of Humanity-Oriented Science and Engineering, Kindai University

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



Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

2017 Year 01 Month 30 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 03 Day

Last follow-up date

2017 Year 05 Month 01 Day

Date of closure to data entry

2017 Year 05 Month 08 Day

Date trial data considered complete

2017 Year 08 Month 01 Day

Date analysis concluded

2017 Year 10 Month 14 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 02 Day

Last modified on

2018 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name