UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the combined ingestion of plant-derived ingredients on the serum triglyceride levels
Acronym	Effect of the combined ingestion of plant-derived ingredients on the serum triglyceride levels
Scientific Title	Effect of the combined ingestion of plant-derived ingredients on the serum triglyceride levels
Scientific Title:Acronym	Effect of the combined ingestion of plant-derived ingredients on the serum triglyceride levels
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the TG-lowering effect of the ingredients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the fasting serum TG level after 4 weeks of daily ingestion of ingredients
Key secondary outcomes	Evaluation of the lipid profile after 4 weeks of daily ingestion of ingredients

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	continuous ingestion of the placebo beverage for 4 weeks
Interventions/Control_2	continuous ingestion of the test beverage 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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy males and postmenopausal females TG <= 120mg/dL and >= 200mg/dL in screening
Key exclusion criteria	1) under treatment for severe disease 2) history of or under treatment for gastrointestinal disorder 3) taking therapeutic medicine 4) taking functional food for lipid management. 5) heavy drinker and smoker 6) Subjects who have been to get sick by collecting venous blood 7) food allergy 8) Subjects who are planned to participate in other clinical study during current study. 9) Subjects who are judged to be inappropriate for the study by the medical doctor
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Masanobu Middle name Last name Hibi
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	31-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL	+81-3-5630-7266
Email	hibi.masanobu@kao.com

Public contact
Name of contact person	1st name Yuji Middle name Last name Matsui
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	31-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL	+81-3-5630-7266
Homepage URL
Email	matsui.yuji@kao.com

Sponsor
Institute	Kao Corporation
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	Utsukushigaoka Hospital
Address	61-1, Mae, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
Tel	011-882-0111
Email	matsuda@ughp-cpc.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	医療法人北武会美しが丘病院（北海道）

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 08 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	36
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	2017 Year 08 Month 17 Day
Date of IRB	2017 Year 08 Month 17 Day
Anticipated trial start date	2017 Year 08 Month 17 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 08 Day
Last modified on	2021 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049402