UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020271 |
|---|---|
| Receipt number | 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 09:52:07 |
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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
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
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
New Drug Research Center, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023402
