UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033873
Receipt number R000038632
Scientific Title Study for evaluating the safety of excessive intake of food containing plant-derived constituent
Date of disclosure of the study information 2018/09/01
Last modified on 2019/02/22 11:21:06

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Basic information

Public title

Study for evaluating the safety of excessive intake of food containing plant-derived constituent

Acronym

Study for evaluating the safety of excessive intake of food

Scientific Title

Study for evaluating the safety of excessive intake of food containing plant-derived constituent

Scientific Title:Acronym

Study for evaluating the safety of excessive intake of food

Region

Japan


Condition

Condition

None (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive intake of food containing plant-derived constituent

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Interview by physician
2. Height and body weight
3. Blood pressure and pulse
4. Hematological test
5. Biochemical test
6. Urine analysis
7. Subjective symptom and objective response
8. Adverse events

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

Food containing plant-derived constituent, 12 portion of food per day for 4 weeks.

Interventions/Control_2

Placebo food, 12 portion of food per day for 4 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)Healthy males and females aged from 20 to less than 65 years old when giving the informed consent.
(2)Subjects with BMI from 18.5 to less than 30 kg/m2 at the screening.
(3)Subjects giving the informed consents in writing after receiving explanation of the purpose and details of the study, understanding the study and deciding to attend the study with their own will.

Key exclusion criteria

(1)Subjects on a diet.
(2)Subjects using medication affecting lipid metabolism.
(3)Subjects constantly using supplements or functional foods affecting lipid metabolism (including foods for specified health uses and foods with function claims).
(4)Subjects using foods containing ingredients of test food constantly.
(5)Subjects with excessive alcohol-drinking behaviors (maximum daily quantity: approximately 20 g of pure alcohol per day).
(6)Subjects who cannot stop drinking for two days until the screening and each checkup.
(7)Subjects with food allergy.
(8)Subjects with serious diseases (e.g., diabetes, kidney disease, liver disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorders.
(9)Subjects with chronic diseases and using medicines continuously.
(10)Subjects having a medical history of diseases affecting digestion and absorption.
(11)Subjects with implantable medical devices (e.g., cardiac pace maker and implantable defibrillator)
(12)Subjects judged unsuitable for the study based on the results of blood test.
(13)Subjects with anemia.
(14)Subjects having donated over 200 mL of blood or blood component within the last one month prior to the current study or over 400 mL of blood or blood component within the last three months prior to the current study.
(15)Subjects diagnosed with familial hyperlipidemia.
(16)Subjects under treatment or a history of drug addiction and/or alcoholism.
(17)Subjects participating or willing to participate in other clinical studies with the intake of food or pharmaceutical products, or with the swab of cosmetic or pharmaceutical products.
(18)Subjects who are pregnant, breastfeeding, or planning to be pregnant in the near future.
(19)Subjects working for a company developing or manufacturing functional foods.
(20)Subjects judged unsuitable for this study by the investigator for other reasons.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Iwama

Organization

Nihonbashi Cardiovascular Clinic

Division name

Director

Zip code


Address

Kyodo Building #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo, Japan

TEL

03-5641-4133

Email

yiwama@well-sleep.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales Department

Zip code


Address

Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo, Japan

TEL

03-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Kirin company, Limited

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


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



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 01 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

2018 Year 08 Month 09 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 06 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

2018 Year 08 Month 23 Day

Last modified on

2019 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038632


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name