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 subjects
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 blood, urine, and stool *1 Assessed sodium, calcium, magnesium, and iron in minerals *2 Collected blood samples at baseline, 30 min, 60 min, 90 min, and 120 min *3 Collected urine at baseline, 2, 4, 6, 8, and 24 hours after intake *4 Collected stool at 24 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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: single dose Test food: active food 1, active food 2, and placebo food Administration: Eat test food with water during meal <Intervention schedule A> [1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner. [2] Washout period is for 4 days. [3] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner. [4] Washout period is for 4 days. [5] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner. <Intervention schedule B> [1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner. [2] Washout period is for 4 days. [3] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner. [4] Washout period is for 4 days. [5] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner. *The allocation is performed according to Latin square. When intervention schedule A is applied, all intervention schedule B are rejected (vice versa).
Interventions/Control_2	Duration: same as above Test material: same as above Administration: same as above <Intervention schedule A> [1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner. [2] Washout period is for 4 days. [3] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner. [4] Washout period is for 4 days. [5] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner. <Intervention schedule B> [1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner. [2] Washout period is for 4 days. [3] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner. [4] Washout period is for 4 days. [5] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner. *The allocation is performed according to Latin square. When intervention schedule A is applied, all intervention schedule B are rejected (vice versa).
Interventions/Control_3	Duration: same as above Test material: same as above Administration: same as above <Intervention schedule A> [1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner. [2] Washout period is for 4 days. [3] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner. [4] Washout period is for 4 days. [5] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner. <Intervention schedule B> [1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner. [2] Washout period is for 4 days. [3] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner. [4] Washout period is for 4 days. [5] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner. *The allocation is performed according to Latin square. When intervention schedule A is applied, all intervention schedule B are rejected (vice versa).
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult men or menopause women for 1 or more year 2. Subjects who defecate every morning at their home 3. Subjects who can eat the prescribed diet for breakfast, lunch, and dinner 4. Subjects who have a regular bowel movement once a day in the morning 5. Subjects who can send their stool and urine after collecting stool in the morning 6. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, kidney stone, cerebrovascular disorder, rheumatism, diabetes mellitus, hypercalcemia, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who regularly take calcium-rich foods such as calcium-fortified milk 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 6. Subjects who have physical labor in perspiration 7. Subjects who work late-night shift and the lifestyles are irregular 8. Subjects who cannot control their room temperature including not having any air conditioners and heaters 9. Subjects who have a tendency toward constipation or diarrhea 10. Subjects who have excessive fitness habit 11. Subjects who have a drinking habit 12. Subjects who are currently taking medications (including herbal medicines) and dietary supplements 13. Subjects who are an allergic reaction to medications and/or the test food related products 14. Subjects who are pregnant, breast-feeding, or planning to become pregnant 15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 16. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Middle name Last name Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
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	Medical Corporation Seishinkai, Takara Clinic
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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 22 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	2018 Year 10 Month 31 Day
Date of IRB	2018 Year 10 Month 31 Day
Anticipated trial start date	2018 Year 11 Month 24 Day
Last follow-up date	2019 Year 06 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 22 Day
Last modified on	2019 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039879