UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000033451
Receipt No. R000038144
Scientific Title A study on absorption of plant-derived constituent.
Date of disclosure of the study information 2018/07/20
Last modified on 2019/08/26 (Ver. 6)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information
Public title A study on absorption of plant-derived constituent.
Acronym A study on absorption of plant-derived constituent.
Scientific Title A study on absorption of plant-derived constituent.
Scientific Title:Acronym A study on absorption of plant-derived constituent.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate a related factor to absorption of a plant-derived constituent
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood concentration of metabolite after a single oral ingestion of plant-derived constituent
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Single oral ingestions of the test constituent contained the two test foods with different composition with more than 5-day washout between the interventions.

Observation for 5 hours after the ingestion.

Ingestion order: "food A" to "food B"
Interventions/Control_2 Single oral ingestions of the test constituent contained the two test foods with different composition with more than 5-day washout between the interventions.

Observation for 5 hours after the ingestion.

Ingestion order: "food B" to "food A"
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1. 20<=Age<60 of healthy men and women
2. provided written informed consent from subjects
Key exclusion criteria 1.Liver, kidney, heart disease, disorder respiration endocrine, metabolism, nervous system consciousness, diabetes, or other diseases
2. Medicine use against hyperglycemia or hyperlipidemia.
3. Blood donation of 200 mL or more within l month of this trial
4. Unpleasant feeling during blood drawing
5. Allergy against any constituents in the test diet
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 Biological Science Research
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7456
Email saito.shinichiro@kao.com

Public contact
Name of contact person
1st name Chizuka
Middle name
Last name Suzuki
Organization Kao Corporation
Division name Biological Science Research
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7456
Homepage URL
Email suzuki.chizuka@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kao Corporation Human Research IRB
Address 2-1-3 Bunka Sumida-ku Tokyo
Tel +81-3-5630-7263
Email morisaki.naoko@kao.com

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 07 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 5
Results 
No significant difference in the primary outcome
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 
5 participants completed and 5 subjects were incorporated into the analyses
Adverse events 
No adverse effect related to the test diets reported
Outcome measures 
Blood concentration of metabolite after a single oral ingestion of plant-derived consituent
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2018 Year 07 Month 18 Day
Date of IRB
2018 Year 07 Month 18 Day
Anticipated trial start date
2018 Year 07 Month 23 Day
Last follow-up date
2018 Year 08 Month 10 Day
Date of closure to data entry
2018 Year 08 Month 26 Day
Date trial data considered complete
2018 Year 08 Month 27 Day
Date analysis concluded
2018 Year 11 Month 13 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 19 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=R000038144