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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030411
Receipt No. R000034652
Scientific Title The effect of test food on night-time urinary electrolyte excretion and pharmacokinetics of the metabolites in healthy volunteers
Date of disclosure of the study information 2019/04/01
Last modified on 2019/10/24

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Basic information
Public title The effect of test food on night-time urinary electrolyte excretion and pharmacokinetics of the metabolites in healthy volunteers
Acronym The effect of test food on night-time urinary electrolyte excretion in healthy volunteers
Scientific Title The effect of test food on night-time urinary electrolyte excretion and pharmacokinetics of the metabolites in healthy volunteers
Scientific Title:Acronym The effect of test food on night-time urinary electrolyte excretion in healthy volunteers
Region
Japan

Condition
Condition Healthy Volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of test food on urinary electrolyte excretion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urinary electrolyte
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Placebo(single ingestion) - washout period - test food(single ingestion)
Interventions/Control_2 Test food(single ingestion) - washout period - Placebo(single ingestion)
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Healthy males aged between 30 and 64. Healthy post-menopausal females aged between 50 and 64 with no menstruation in the past 12 months.
2)Subjects who 24hr Urinary sodium in screening examination is lower.
3)Subjects who routinely not take medicine, supplements, FOSHU, and/or health food which affect to the result of the study.
Key exclusion criteria 1) Subjects who have allergy to medicinal and foods.
2) Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease).
3) Subjects who systolic blood pressure is more than 140 mmHg or diastolic blood pressure is more than 90 mmHg.
4) Subjects who BMI is more than 30 kg/m2.
5) Subjects who make a blood donation of 400 ml within 12 weeks before the start of the intake or that of 200 ml within 4 weeks before the start of the intake.
6) Subjects who are estimated inappropriate to participate to this study by principal investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuneyuki Noda
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Saga Nutraceuticals Research Institute
Zip code
Address 5006-5 Yoshinogari, Kanzaki, Saga
TEL 0952-52-1522
Email Noda.Tsuneyuki@otsuka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuneyuki Noda
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Saga Nutraceuticals Research Institute
Zip code
Address 5006-5 Yoshinogari, Kanzaki, Saga
TEL 0952-52-1522
Homepage URL
Email Noda.Tsuneyuki@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical 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 大塚製薬株式会社 佐賀栄養製品研究所 (佐賀県)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 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
2017 Year 11 Month 07 Day
Date of IRB
2017 Year 11 Month 07 Day
Anticipated trial start date
2017 Year 12 Month 16 Day
Last follow-up date
2018 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 15 Day
Last modified on
2019 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034652

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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