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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020271
Receipt No. R000023402
Scientific Title Safety evaluation of the consumption of plant-derived processed product in healthy adults: a double-blind, randomized controlled trial with parallel group design.
Date of disclosure of the study information 2016/01/20
Last modified on 2019/08/26

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Basic information
Public title Safety evaluation of the consumption of plant-derived processed product in healthy adults: a double-blind, randomized controlled trial with parallel group design.
Acronym Safety evaluation of plant-derived processed product
Scientific Title Safety evaluation of the consumption of plant-derived processed product in healthy adults: a double-blind, randomized controlled trial with parallel group design.
Scientific Title:Acronym Safety evaluation of plant-derived processed product
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of excessive
consumption of a plant-derived
processed product
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of adverse events at 4 weeks after intervention.
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 Treatment
Type of intervention
Food
Interventions/Control_1 Control food(product code,C-002), administration period = 4 weeks, dosage = 30g/day
Interventions/Control_2 Test food(product code,A-002), administration period = 4 weeks, dosage = 30g/day
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 -BMI>=22.0 and<30.0 kg/m2
-BMI>=20 and<65 years old
-Person who provides inforrned
consent by a document
Key exclusion criteria 1) individual with liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases, 2) individual given surgery within 2 months before the trial, 3) medicine user for hyperglycaemia, lipidemia, or hypertension, 4) individual intakes supplements or the food for specific use of health authorized the government, 5) individual experienced unpleasant feeling during blood drawing, 6) individual donated 200 mL or more blood within 1 month before the trial, 7) individual changed his/her weight 2 kg or more within 1 month before the trial, 8) shiftworker, 9) individual plans bussiness trip for 10 consecutive days or more, 10) individual had allergy against any constituents in the test diet, 11) individual can not conform to alcohol limitation, 12) individual can not conform to record of daily life in a format, 13) individual can not conform to record of daily diet for 9 days (3 days x 3 times), 14) individual cannot allow operator to consult his/her data of the past health check, 15) individual have already participated other clinical trial and will participate, 16) individual cannot accept content of this trial, 17) pregnant women or breast-feeding women, 18) individual who was judged ineligibles by clinician in this trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Shinichiro
Middle name
Last name Saito
Organization Kao Corporation
Division name Health Care Food Research Labs.
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 0356307456
Email saito.shinichirou@kao.com

Public contact
Name of contact person
1st name Shinpei
Middle name
Last name Tomita
Organization New Drug Research Center, Inc.
Division name Clinical Research Dept.
Zip code 061-1405
Address 452-1 Toiso, Eniwa-shi, Hokkaido
TEL 0123-34-0412
Homepage URL
Email s-tomita@ndrcenter.co.jp

Sponsor
Institute New Drug Research Center, Inc.
Institute
Department

Funding Source
Organization Kao Corporation
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 The Ethics Review Board of Miyawaki Orthopedic Hospital
Address 3-1-6 Ariake-cho, Eniwa city, Hokkaido
Tel 0123-33-4026
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
2016 Year 01 Month 20 Day

Related information
URL releasing protocol Unpublished due to the protocol including the intellectual property rights
Publication of results Published

Result
URL related to results and publications works in progress
Number of participants that the trial has enrolled 30
Results
The results suggest that the excessive consumption of test food is safe in healthy subjects.
Results date posted
2019 Year 08 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy
Participant flow
30 participants completed and 30 subjects were incorporated into the analyses
Adverse events
	
No adverse effect related to the test diets reported
Outcome measures
Safety
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 12 Month 15 Day
Date of IRB
2015 Year 12 Month 15 Day
Anticipated trial start date
2016 Year 01 Month 24 Day
Last follow-up date
2016 Year 03 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 18 Day
Last modified on
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023402

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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