UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043825
Receipt number R000050020
Scientific Title Safety evaluation of an excessive consumption of food material - Randomized, double-blind, placebo-controlled parallel group study -
Date of disclosure of the study information 2021/04/02
Last modified on 2021/10/01 18:29:11

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Basic information

Public title

Safety evaluation of an excessive consumption of food material
- Randomized, double-blind, placebo-controlled parallel group study -

Acronym

Safety evaluation of an excessive consumption of food material

Scientific Title

Safety evaluation of an excessive consumption of food material
- Randomized, double-blind, placebo-controlled parallel group study -

Scientific Title:Acronym

Safety evaluation of an excessive consumption of food material

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of food material for 4
weeks

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Expression rate of side effect, Expression rate of Adverse event , clinical examination items, physiological examination items

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test food
5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 weeks.

Interventions/Control_2

Control food
5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 weeks.

Interventions/Control_3


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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1)Males and females equal to or more than 20 years and less than 65 years of age
2)Subjects who visit on schedule days
3)Subjects who recognize the object and contents of the study and submit the written informed consent

Key exclusion criteria

1)Subjects who BMI >=30.0 kg/m2 or <18.5 kg/m2
2)Subjects who have systolic blood pressure <90 mmHg
3)Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study
4)Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs
5)Subjects who regularly use drugs, health foods, and supplements
6)Females in pregnancy, lactation and scheduled pregnancy during test period.
7)Heavy alcoholic beverager(40g alcohol/day>=), heavy smoker(21 cigarettes/day>=)
8)Subjects who feel bad mood by blood collection in past
9)Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period
10)Night shift worker
11)Don't usually have breakfast
12)Subjects who plan business trip or trip for 10 days or more a month
13)Subjects who have allergy related to the study foods
14)Those who have been diagnosed with chronic constipation
15)Dysphagic person
16)Subjects already participating in other clinical trials
17)Subjects who are ineligible due to physician's judgement

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Ikuo
Middle name
Last name Fukuhara

Organization

Fukuhara Clinic

Division name

Hospital director

Zip code

061-1351

Address

3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido, Japan

TEL

0123-36-8029

Email

i-feniwa@gray.plala.or.jp


Public contact

Name of contact person

1st name Toyotada
Middle name
Last name Ashino

Organization

New drug research center, Inc.

Division name

Clinical Research Dept.

Zip code

061-1405

Address

452-1 Toiso, Eniwa-shi, Hokkaido, Japan

TEL

0123-34-0412

Homepage URL


Email

t-ashino@ndrcenter.co.jp


Sponsor or person

Institute

Maruzen Pharmaceuticals Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Maruzen Pharmaceuticals Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukuhara Clinic Clinical Trial Review Committee

Address

1-15, Shimamatsuhigashimachi-3-chome, Eniwa-shi, Hokkaido

Tel

0123-36-8029

Email

d-kameda@mediffom.co.jp


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



Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 02 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

2021 Year 03 Month 24 Day

Date of IRB

2021 Year 03 Month 22 Day

Anticipated trial start date

2021 Year 04 Month 26 Day

Last follow-up date

2021 Year 06 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 04 Month 02 Day

Last modified on

2021 Year 10 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050020


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name