UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038650 |
|---|---|
| Receipt number | R000043386 |
| Scientific Title | Examination of the effect of ingection of the test food on cholesterol metabolism, BMI, and body fat. |
| Date of disclosure of the study information | 2019/11/22 |
| Last modified on | 2021/05/31 17:06:53 |
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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
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
mizoshun@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043386
| Research Plan | |
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| Registered date | File name |
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