UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020272
Receipt No. R000023403
Scientific Title Bioequivalence study of the consumption of plant-derived processed product with anti-obesity in healthy adults
Date of disclosure of the study information 2016/01/20
Last modified on 2019/08/26 (Ver. 10)

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Basic information
Public title Bioequivalence study of the consumption of plant-derived processed product with anti-obesity in healthy adults
Acronym Bioequivalence study of plant-derived processed product in healthy adults.
Scientific Title Bioequivalence study of the consumption of plant-derived processed product with anti-obesity in healthy adults
Scientific Title:Acronym Bioequivalence study of plant-derived processed product in healthy adults.
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 bioequivalence of original product A-001and generic product A-002
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AUC0-8hr and Cmax of postprandial triglyceride
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Product code A-002(1day, 1time, 10g), washout(over 6days), product code A-001(1day, 1time, 10g)
Interventions/Control_2 Product code A-001(1day, 1time, 10g), washout(over 6days), product code A-002(1day, 1time, 10g)
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
35 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)BMI>=23.0and<30.0 kg/m2
2)Age>=35 and<65 years old
3)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) heavy smoker (cigarettes>=21/day), 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 record of daily diet for 6 days (3 days x 2 times), 12) individual cannot allow operator to consult his/her data of the past health check, 13) individual have already participated other clinical trial and will participate, 14) pregnant women or breast-feeding women, 15) individual who was judged ineligibles by clinician in this trial
Target sample size 20

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 131-6501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7456
Email shoji.kentaro@kao.co.jp

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 福原医院

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 17
Results 
he result suggested that there was bioequivalence between test food and control food.
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 subjects
Participant flow 
20 participants completed and 17 subjects were incorporated into the analyses
Adverse events 
No adverse effect related to the test diets reported
Outcome measures 
AUC0-8hr and Cmax of postprandial triglyceride
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 04 Month 14 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=R000023403