UMIN-CTR Clinical Trial

Public title

Examination of postprandial urinary salt excretion during test food intake for adult males

Acronym

Examination of postprandial urinary salt excretion during test food intake for adult males

Scientific Title

Examination of postprandial urinary salt excretion during test food intake for adult males

Scientific Title:Acronym

Examination of postprandial urinary salt excretion during test food intake for adult males

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The sodium excretion effect and safety of foods containing plant extracts after 2 consecutive weeks of ingestion will be examined using placebo as a control.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Urinary salt excretion at 2 weeks ingestion

Key secondary outcomes

1. Total Body Water
2. blood pressure
3. QOL Questionnaire

Study type

Interventional

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

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food for 2 consecutive weeks

Interventions/Control_2

Intake of placebo food for 2 consecutive 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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male

Key inclusion criteria

(1) Healthy males from 20 to 64 years of age
(2) Subjects with systolic blood pressure of 130 mmHg to 159 mmHg and / or diastolic blood pressure of 85 mmHg to 99 mmHg

Key exclusion criteria

(1) Subjects who are going to the hospital or taking medication for the treatment of dysuria
(2) Subjects who are on or will be on a diet during the study period
(3) Subjects with excessive drinking habits
(4) Subjects who habitually take health foods, quasi-drugs, and medicines that have a blood pressure lowering effect
(5) Subjects with smoking habits
(6) Subjects currently diagnosed with arrhythmia
(7) Subjects who take health foods, quasi-drugs, and medicines that strengthen the ingredients involved in research foods at least once a week
(8) Subjects who take health foods, quasi-drugs, and medicines that are said to be effective in salt excretion at least once a week
(9) Subjects with or with renal disease, urethral stones
(10) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(11) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(12) Subjects having possibilities for emerging allergy related to the study
(13) Subjects whose physical measurements and physical examination values before the start of ingestion were significantly out of the standard range
(14) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(15) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(16) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

16

Name of lead principal investigator

1st name	Tetsuya
Middle name
Last name	Hirata

Organization

Kobayashi Pharmaceutical Co., Ltd.

Division name

Central R&D Laboratory

Zip code

567-0057

Address

1-30-3, Toyokawa, Ibaraki-city, OSAKA, JAPAN

TEL

072-3542-7730

Email

t.hirata@kobayashi.co.jp

Name of contact person

1st name	Shinsuke
Middle name
Last name	Tsuji

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

s.tsuji@ttc-tokyo.co.jp

Institute

TTC Co., Ltd

Institute

Department

Personal name

Organization

Kobayashi Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

t.saito@ttc-smo.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2020

Year

10

Month

22

Day

Date of IRB

2020

Year

10

Month

22

Day

Anticipated trial start date

2020

Year

10

Month

26

Day

Last follow-up date

2020

Year

11

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

10

Month

23

Day

Last modified on

2021

Year

04

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048203