UMIN-CTR Clinical Trial

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

Healthy Japanese adult people

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

NISSIN FOODS HOLDINGS CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2018

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

12

Month

27

Day

Last modified on

2018

Year

07

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034922