UMIN-CTR Clinical Trial

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

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

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

Central registration

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

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

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

San-ei Sucrochemical 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

11

Month

22

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

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 related information

Registered date

2018

Year

11

Month

22

Day

Last modified on

2019

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039879