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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034759
Receipt No. R000039640
Official scientific title of the study Examination of the effect of ingection of the test food on cholesterol metabolism, BMI, and body fat.
Date of disclosure of the study information 2018/11/09
Last modified on 2018/11/12

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Basic information
Official scientific title of the study Examination of the effect of ingection of the test food on cholesterol metabolism, BMI, and body fat.
Title of the study (Brief title) 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
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.Those who can understand the purpose and the contents of this study and can agree to participate to this study by letter.
2. Individuals whose BMI is >=23 and <30.
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 and LDL cholesterol <140 mg/dL.
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 Prof. Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical nursing
Address Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-866-5811
Email mizoshun@kochi-u.ac.jp

Public contact
Name of contact person Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical nursing
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 Japan

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

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 高知大学医学部(高知県)、高知大学医学部附属病院(高知県)、高知工科大学(高知県)、医療法人 仁泉会 朝倉病院(高知県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 09 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 10 Month 15 Day
Anticipated trial start date
2018 Year 11 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 04 Day
Last modified on
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039640

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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