UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effect of ingection of the test food on cholesterol metabolism, BMI, and body fat.
Acronym	Examination of the effect of the test food on cholesterol metabolism, BMI, and body fat.
Scientific Title	Examination of the effect of ingection of the test food on cholesterol metabolism, BMI, and body fat.
Scientific Title:Acronym	Examination of the effect of the test food on cholesterol metabolism, BMI, and body fat.
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to demonstrate that ingestion of the test food is effective for cholesterol metabolism, BMI, and body fat.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body Mass Index(BMI) Body fat percentage Blood LDL-Cholesterol
Key secondary outcomes	Blood glucose level ALT, AST Insulin HbA1c Adiponectin

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of 4 capsules of test food 1 daily for 24 weeks.
Interventions/Control_2	Oral ingestion of 4 capsules of test food 2 daily for 24 weeks.
Interventions/Control_3	Oral ingestion of 4 placebo capsules daily for 24 weeks.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Individuals who can understand the purpose and contents of this study and can agree to participate in this study by letter. 2. Individuals whose BMI is >=23 and <30 kg/m2. 3. Individuals whose internal organ fat level is less than 10 on a body composition meter. 4. Individuals whose fasting blood test results are blood glucose <126 mg/dL, low-density lipoprotein cholesterol <140 mg/dL, alanine transaminase <=45, and aspartate transaminase <=40.
Key exclusion criteria	Individuals meeting any of the following conditions will not be selected as study subjects: 1. Pregnant and nursing mothers, and individuals with a desire to become pregnant during the study period 2. Individuals taking medication on a routine basis 3. Individuals who are taking foods for specific health use, foods with function claims, and/or health foods, in the case that such foods affect blood lipid levels or blood sugar level. 4. Individuals with gelatin allergy. 5. Individuals with inflammatory bowel disease 6. Other individuals deemed unsuitable by the principal investigator.
Target sample size	99

Research contact person
Name of lead principal investigator	1st name Shunji Middle name Last name Mizobuchi
Organization	Kochi Medical School, Kochi University
Division name	Clinical nursing
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL	088-866-5811
Email	mizoshun@kochi-u.ac.jp

Public contact
Name of contact person	1st name Shunji Middle name Last name Mizobuchi
Organization	Kochi Medical School, Kochi University
Division name	Clinical nursing
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL	088-866-5811
Homepage URL
Email	mizoshun@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Kochi Prefectural Government
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kochi Medical School, Center for Next Generation Medicine
Address	Kohasu,Oko-cho,Nankoku-city,Kochi,Japan
Tel	088-880-2719
Email	im62@kochi-u.ac.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	2019 Year 11 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	99
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 10 Month 07 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2019 Year 11 Month 25 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 10 Month 26 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 21 Day
Last modified on	2021 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043386