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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030586
Receipt No. R000034922
Scientific Title Evaluation of the effects on enhancing elimination of minerals in the body: a randomized, double-blind, placebo-controlled, crossover trial
Date of disclosure of the study information 2018/06/29
Last modified on 2018/07/19

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Basic information
Public title Evaluation of the effects on enhancing elimination of minerals in the body: a randomized, double-blind, placebo-controlled, crossover trial
Acronym Evaluation of the effects on enhancing elimination of minerals in the body
Scientific Title Evaluation of the effects on enhancing elimination of minerals in the body: a randomized, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym 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
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 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)

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 06 Month 29 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 12 Month 11 Day
Date of IRB
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

Other
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

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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