UMIN-CTR Clinical Trial

Basic information
Public title	A Study on Lipid Improvement Effect of Food Containing Plant Extract -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym	A Study on Lipid Improvement Effect of Food Containing Plant Extract
Scientific Title	A Study on Lipid Improvement Effect of Food Containing Plant Extract -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym	A Study on Lipid Improvement Effect of Food Containing Plant Extract
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the lipid improvement effect of food containing plant extract
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LDL-cholesterol Triglyceride
Key secondary outcomes	Other lipid metabolism markers Body fat and liver function markers

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	Foods containing plant extract, 12 weeks consumption
Interventions/Control_2	Foods not containing plant extract, 12 weeks consumption
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	(1) Healthy males and females aged 20 to 64 years-old. (2) Subjects whose LDL-cholesterol levels are 139 mg/dL or less, or triglyceride levels are 149 mg/dL or less by the screening tests. (3) Subjects whose HDL-cholesterol levels are 40 mg/dL or over. (4) Subjects whose BMI are under 30. (5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects who use medications affecting obesity, hyperlipidemia, lipid metabolism. (2) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity, hyperlipidemia, lipid metabolism. (4) Subjects with tendency of diarrhea or who have diarrhea within 2 weeks before the screening test. (5) Subjects who are shift workers and/or night-shift workers. (6) Subjects who were pregnant or planned to become pregnant or breastfeed during the study period. (7) Subjects who have been diagnosed as familial hyperlipidemia. (8) Subjects with a history of and/or current drug addiction and/or alcoholism. (9) Subjects who were planning to participate and/or had participated in other clinical studies within the month prior to the commencement of the current study. (10) Subjects who were judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Tokushima
Organization	Maebashi North Hospital
Division name	Director
Zip code	371-0054
Address	692 Shimohosoi-machi,Maebashi-shi,Gunma
TEL	027-235-3333
Email	sagawa@mc-connect.co.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TOYO SHINYAKU Co., Ltd.
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	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel	027-212-5608
Email	sagawa@mc-connect.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	2021 Year 03 Month 19 Day

Related information
URL releasing protocol	https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049863
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/50010/109
Number of participants that the trial has enrolled	80
Results	Statistically significant difference was confirmed in the primary outcome.
Results date posted	2022 Year 03 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Males and females aged 20 to 64years old.
Participant flow	Enrolled(n=80) Completed(n=79) Analysed(n=64)
Adverse events	No adverse events were observed that be related to test food.
Outcome measures	LDL-cholesterol Triglyceride
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2021 Year 03 Month 18 Day
Date of IRB	2021 Year 03 Month 18 Day
Anticipated trial start date	2021 Year 03 Month 22 Day
Last follow-up date	2021 Year 08 Month 06 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 03 Month 19 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049863