UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effects on enhancing elimination of minerals in the body: a randomized, double-blind, placebo-controlled, crossover trial
Title of the study (Brief title)	Evaluation of the effects on enhancing elimination of minerals in the body
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 on enhancing elimination of minerals in the body with the intake of the test food
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Sodium concentration in stool 2. Sodium concentration in urine * For urine evaluation, collect the urine from after eating the prescribed diet, eating test food, and the dye capsule. For stool evaluation, collect the stools in the next morning after eating the prescribed diet, eating test food, and the dye capsule.
Key secondary outcomes	1. Mineral concentration in stool Concentrations of potassium, calcium, magnesium, phosphorus, copper, zinc, manganese, and iron 2. Mineral Concentration in urine Concentrations of potassium, calcium, magnesium, phosphorus, iodine, selenium, chromium, and molybdenum 3. Questionnaires about hunger and sleepiness (by the Visual Analogue Scale; VAS) 4. Stool examination stool weight, stool moisture, crude protein, crude fat, crude ash, crude fiber *1, 2, 4 Assess by using the collected stools sample in the next morning after eating the prescribed diet, eating test food, and the dye capsule. *3 Assess the questionnaires after eating the prescribed diet, eating test food, and the dye capsule.

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	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: single dose Test material: Test food 1, Test food 2, and placebo food Administration: Take 16 capsules and one dye capsule, which make stool dye, with at least 240 mL of water after eating breakfast (the prescribed diet) <Intervention schedule A> [1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet for breakfast and then take Test food 1 and the dye capsule. 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 for breakfast and then take Test food 2 and the dye capsule. 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 for breakfast and then take placebo food and the dye capsule. 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 for breakfast and then take Test food 1 and the dye capsule. 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 for breakfast and then take placebo food and the dye capsule. 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 for breakfast and then take Test food 2 and the dye capsule. 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 for breakfast and then take Test food 2 and the dye capsule. 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 for breakfast and then take placebo food and the dye capsule. 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 for breakfast and then take Test food 1 and the dye capsule. 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 for breakfast and then take Test food 2 and the dye capsule. 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 for breakfast and then take Test food 1 and the dye capsule. 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 for breakfast and then take placebo food and the dye capsule. 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 for breakfast and then take placebo food and the dye capsule. 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 for breakfast and then take Test food 1 and the dye capsule. 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 for breakfast and then take Test food 2 and the dye capsule. 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 for breakfast and then take placebo food and the dye capsule. 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 for breakfast and then take Test food 2 and the dye capsule. 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 for breakfast and then take Test food 1 and the dye capsule. 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
Key inclusion criteria	1. Healthy Japanese male people who defecate every morning at their home 2. Subjects who can eat the prescribed diet for breakfast, lunch, and dinner 3. Subjects who can send their stools and urine samples by parcel delivery service after collected sample in the morning 4. Subjects who have a regular bowel movement once a day in the morning 5. Subjects who can collect their urine for 24 hours on the collected urine day 6. Subjects who can take 16 capsules (2.2 cm x 0.77 cm) after eating breakfast 7. Subjects who are judged as eligible to participate in the study by the physician 8. Subjects who are confirmed dyed stools ONCE in the next morning after eating the prescribed diet with the dye capsule at both screening 1 and 2
Key exclusion criteria	1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, intestinal disorder or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products. Particularly allergic to ribwort (Plantains) pollen, grass pollen, and melon 6. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 7. Subjects who are judged as ineligible to participate in the study by the physician 8. Subjects who have physical labor such as sweats 9. Subjects who cannot control their room temperature including not have any air conditioner 10. Subjects who have a tendency toward constipation or diarrhea 11. Subjects who have a fitness habit 12. Subjects who have a drinking habit
Target sample size	21

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
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	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
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	NISSIN FOODS HOLDINGS 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)

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 06 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 11 Day
Anticipated trial start date	2017 Year 12 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 27 Day
Last modified on	2018 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034922