UMIN-CTR Clinical Trial

Basic information
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
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Urinary salt excretion at 2 weeks ingestion
Key secondary outcomes	1. Total Body Water 2. blood pressure 3. QOL 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
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Kobayashi Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
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	2021 Year 11 Month 27 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	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
Other related information

Management information
Registered date	2020 Year 10 Month 23 Day
Last modified on	2021 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048203