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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041709
Receipt No. R000047609
Scientific Title An investigation of mineral absorption: a randomized, double-blind, placebo-controlled, crossover trial.
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/07

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Basic information
Public title An investigation of mineral absorption: a randomized, double-blind, placebo-controlled, crossover trial.
Acronym An investigation of mineral absorption
Scientific Title An investigation of mineral absorption: a randomized, double-blind, placebo-controlled, crossover trial.
Scientific Title:Acronym An investigation of mineral absorption
Region
Japan

Condition
Condition Healthy Japanese adult people
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of the intake of test food on minerals absorption on healthy Japanese adult subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Minerals in the urine

*1 Assessed Calcium, magnesium, iron, and Zinc in minerals

*2 Collected urine at baseline, 2, 4, 6, and 8 hours after intake
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: single dose
Test food: active food and placebo food
Administration: Eat test food with water during meal

I. Eat the prescribed diet (without milk) with placebo food for breakfast. Eat the prescribed diet for lunch.
II. Eat the prescribed diet (with milk) with active food for breakfast. Eat the prescribed diet for lunch.
III. Eat the prescribed diet (with milk) with placebo food for breakfast. Eat the prescribed diet for lunch.

*The intervention sequence is I-II-III.
*Washout period is for 4 days and more.
Interventions/Control_2 Duration: single dose
Test food: active food and placebo food
Administration: Eat test food with water during meal

I. Eat the prescribed diet (without milk) with placebo food for breakfast. Eat the prescribed diet for lunch.
II. Eat the prescribed diet (with milk) with placebo food for breakfast. Eat the prescribed diet for lunch.
III. Eat the prescribed diet (with milk) with active food for breakfast. Eat the prescribed diet for lunch.

*The intervention sequence is I-II-III.
*Washout period is for 4 days and more.
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
25 years-old >=
Gender Male and Female
Key inclusion criteria 1. Japanese adult male and female
Key exclusion criteria 1. A medical history of malignant tumor, heart failure or myocardial infarction.

2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus.

3. Subjects who are allergic to the test food related products.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Motoko
Middle name
Last name Ohnishi
Organization Chubu University
Division name College of Bioscience and Biotechnology
Zip code 487-8501
Address 1200 Matsumoto-cho, Kasugai-city, Aichi, JAPAN
TEL 0568-51-6328
Email mohnishi@isc.chubu.ac.jp

Public contact
Name of contact person
1st name Daiki
Middle name
Last name Suehiro
Organization San-ei Sucrochemical Co., Ltd.
Division name Research and Development Section
Zip code 478-8503
Address 24-5, Kitahama-machi, Chita-city, Aichi, JAPAN
TEL 0562-55-5197
Homepage URL
Email daiki-suehiro@sanei-toka.co.jp

Sponsor
Institute Chubu University
Institute
Department

Funding Source
Organization San-ei Sucrochemical 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 Chubu University Certified Review Board
Address 1200 Matsumoto-cho, Kasugai-city, Aichi, JAPAN
Tel 0568-51-1141
Email ***@isc.chubu.ac.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 中部大学(愛知県)
Chubu University (Aichi)

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 07 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 06 Day
Date of IRB
2020 Year 07 Month 17 Day
Anticipated trial start date
2020 Year 09 Month 08 Day
Last follow-up date
2020 Year 11 Month 30 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 09 Month 07 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047609

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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