UMIN-CTR Clinical Trial

Basic information
Public title	Examination study of the effect that continuation intake of the lactic acid bacterium food for healthy adults gives to serum cholesterol for 12 weeks
Acronym	Examination study of the effect that continuation intake of the lactic acid bacterium food for healthy adults gives to serum cholesterol for 12 weeks
Scientific Title	Examination study of the effect that continuation intake of the lactic acid bacterium food for healthy adults gives to serum cholesterol for 12 weeks
Scientific Title:Acronym	Examination study of the effect that continuation intake of the lactic acid bacterium food for healthy adults gives to serum cholesterol for 12 weeks
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to investigate the effects on serum cholesterol by male and female who continue to taking test food for 12 weeks who are older 20 years old,aged less than 65 years old, and LDL-Cholesterol is less than 140mg/dL more than 120mg/dL.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LDL-Cholesterol
Key secondary outcomes	Triglyceride Total Cholesterol HDL-Cholesterol High sensitive CRP Apolipoprotein A-I Apolipoprotein B oxidized LDL

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	Prevention
Type of intervention	Food
Interventions/Control_1	12-weeks intake of the test food
Interventions/Control_2	12-weeks intake of the placebo food
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)Japanese male and female aged 20 to 65 years old at the time of the informed consent. 2)Subject with LDL-Cholesterol>=120mg/dL and <140mg/dL. 3)Subject without a daily exercise habit. 4)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1)Subject who smokes a lot. 2)Subject with the diarrheal disease chronically. 3)Subject who is taking medication or under medical treatment. 4)Subject who is under exercise therapy or dietetic therapy. 5)Subject who has an allergy for test food. 6)Subject who has or had a history of either medicine or alcohol dependence syndrome. 7)Subject who has or had a history of mental illness (depression) or sleep disturbance. 8)Subject who is on a night-shift or is a shift worker. 9)Subject whose lifestyle is extremely irregular. 10)Subject who has an unbalanced diet. 11)Subject with the bowel past surgical history,short bowel syndrome, pancreatitis, the existing illness of the biliary tract disease or history. 12)Subject with brain disease, a malignant tumor, immunologic disease, diabetes, hepatic disorder (hepatitis), renal disease, serious disease, thyroid disease, adrenal gland disease such as the heart disorder, and the like, the serious existing illness such as other metabolic disorders, and the like or the history. 13)Subject who uses a health food, a supplement affecting fat metabolism and medical supplies. 14)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 15)Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition. 16)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 17)Subject who can't keep the daily records. 18)Subject who is judged as an inappropriate candidate according to the screening data. 19)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yo Middle name Last name Miyakoshi
Organization	Kaneka Co., Ltd.
Division name	Pharma & Supplemental Nutrition Solutions Vehicle
Zip code	107-6028
Address	1-12-32 Akasaka Minato-ku Tokyo 107-6028 Japan
TEL	050-3133-9895
Email	yo.miyakoshi@kaneka.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Kaneka 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	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.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 05 Month 22 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
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	2019 Year 12 Month 25 Day
Date of IRB	2020 Year 01 Month 17 Day
Anticipated trial start date	2020 Year 02 Month 10 Day
Last follow-up date	2020 Year 05 Month 22 Day
Date of closure to data entry	2020 Year 06 Month 05 Day
Date trial data considered complete	2020 Year 06 Month 16 Day
Date analysis concluded	2020 Year 07 Month 17 Day

Other
Other related information

Management information
Registered date	2020 Year 02 Month 07 Day
Last modified on	2021 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042687