UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042221
Receipt No. R000048203
Scientific Title Examination of postprandial urinary salt excretion during test food intake for adult males
Date of disclosure of the study information 2021/11/27
Last modified on 2021/04/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.