UMIN-CTR Clinical Trial

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

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	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: single dose Test food: active food 1-3 and placebo food Administration: Eat test food with water during meal I. Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch. II. Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch. III.Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch. IV.Eat the prescribed diet with active food 3 for breakfast. Eat the prescribed diet for lunch. *The intervention sequence is I-II-III-IV. *Washout period is for 4 days and more.
Interventions/Control_2	Duration: single dose Test food: active food 1-3 and placebo food Administration: Eat test food with water during meal I. Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch. II. Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch. III.Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch. IV.Eat the prescribed diet with active food 3 for breakfast. Eat the prescribed diet for lunch. *The intervention sequence is II-III-IV-I. *Washout period is for 4 days and more.
Interventions/Control_3	Duration: single dose Test food: active food 1-3 and placebo food Administration: Eat test food with water during meal I. Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch. II. Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch. III.Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch. IV.Eat the prescribed diet with active food 3 for breakfast. Eat the prescribed diet for lunch. *The intervention sequence is III-IV-I-II. *Washout period is for 4 days and more.
Interventions/Control_4	Duration: single dose Test food: active food 1-3 and placebo food Administration: Eat test food with water during meal I. Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch. II. Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch. III.Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch. IV.Eat the prescribed diet with active food 3 for breakfast. Eat the prescribed diet for lunch. *The intervention sequence is IV-I-II-III. *Washout period is for 4 days and more.
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	23

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	***@office.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 10 Month 19 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	23
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 07 Month 08 Day
Date of IRB	2020 Year 07 Month 17 Day
Anticipated trial start date	2020 Year 09 Month 30 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 10 Month 19 Day
Last modified on	2020 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048127