UMIN-CTR Clinical Trial

Public title

A study for safety evaluation of excess consumption of calcium.

Acronym

A study for safety evaluation of excess consumption of calcium.

Scientific Title

A study for safety evaluation of excess consumption of calcium.

Scientific Title:Acronym

A study for safety evaluation of excess consumption of calcium.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines safety of overconsumption (4 weeks) of a test food.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Existence of side effects and adverse events(Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food)

Key secondary outcomes

Doctor's questions, Blood pressure, pulsation, Weight, body fat percentage, BMI, Blood biochemical test, Hematologic test, Urine analysis (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test foods (255g in a day for 4 weeks)

Interventions/Control_2

Interventions/Control_3

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Healthy adults aged 20 to 64 years old.
(2)Subjects giving written informed consent.

Key exclusion criteria

(1)Subjects who are given continuous treatment by taking medicines.
(2)Individuals who excessively take calcium (total(test foods and usual meals) amount of calcium over 2500mg/day).
(3)Subjects who have previous and/or current medical history of kidney stones, Ureteral stones.
(4)Subjects who constantly use oral medicines, functional foods and/or supplements having a possibility of affecting test results.
(5)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
(6)Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
(7)Subjects who excessive alcohol intake.
(8)Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(9)Subjects who have previous medical history of drug and/or food allergy.
(10)Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(11)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(12)Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
(13)Females who donated over 400mL blood and/or blood components within the last four month to the current study.
(14)Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(15)Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(16)Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Haruhi Shimizu

Organization

Maruha Nichiro Corporation

Division name

Chilled foods department

Zip code

Address

3-2-20, Toyosu, Koto-Ku, Tokyo, 135-8608 Japan

TEL

03-6833-4148

Email

har-shimizu@maruha-nichiro.co.jp

Name of contact person

1st name
Middle name
Last name	Hiroyuki Mitsumoto

Organization

Maruha Nichiro Corporation

Division name

Central Research Institute

Zip code

Address

16-2, Wadai, Tsukuba-City, Ibaraki, 300-4295 Japan

TEL

029-864-6712

Homepage URL

Email

h-mitsumoto@maruha-nichiro.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Maruha Nichiro Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2018

Year

02

Month

25

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

02

Month

15

Day

Date of IRB

Anticipated trial start date

2018

Year

02

Month

26

Day

Last follow-up date

2018

Year

04

Month

19

Day

Date of closure to data entry

Date trial data considered complete

2018

Year

05

Month

24

Day

Date analysis concluded

2018

Year

05

Month

31

Day

Other related information

Registered date

2018

Year

02

Month

23

Day

Last modified on

2018

Year

08

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035859