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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033873
Receipt No. 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

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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
Institute KSO Co., Ltd
Institute
Department

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
URL(English) https://upload.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


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