Status Approved
First Submitted Date
2021/02/03
Registered Date
2021/02/10
Last Updated Date
2021/03/17
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005883 |
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Unique Protocol ID | WSOH IRB H2012-01-01 |
Public/Brief Title | Human trial study to evaluate the efficacy and safety of TZ-HVP on decrement of body fat |
Scientific Title | A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of TZ-HVP on decrement of body fat |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | WSOH IRB H2012-01-01 |
Approval Date | 2020-12-24 |
Institutional Review Board Name | Woosuk University Korean Medicine Medical Center Institutional Review Board |
Institutional Review Board Address | 46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do |
Institutional Review Board Telephone | 063-220-8750 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | lee Eun hee |
Title | associate professor |
Telephone | +82-63-220-8606 |
Affiliation | Woosuk University |
Address | 443, samrye-ro, wanju-gun, Jeollabuk-do |
Contact Person for Public Queries | |
Name | Gwak` ji young |
Title | Researcher |
Telephone | +82-63-277-8930 |
Affiliation | BioFoods Story |
Address | 16, Angol 4-gil, Deokjin-gu, Jeonju-si, Jeollabuk-do |
Contact Person for Updating Information | |
Name | Gwak` ji young |
Title | Researcher |
Telephone | +82-63-277-8930 |
Affiliation | BioFoods Story |
Address | 16, Angol 4-gil, Deokjin-gu, Jeonju-si, Jeollabuk-do |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-02-22 Actual | |
Target Number of Participant | 100 | |
Primary Completion Date | ||
Study Completion Date | 2021-09-30 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Woosuk University Korean Medicine Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-02-22 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Teazen |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Teazen |
Organization Type | Others |
7. Study Summary
Lay Summary | The purpose of this study was to evaluate the efficacy and safety of TZ-HVP-related body fat indexes by observing changes in body fat indexes in subjects who were overweight or obese. The participants in this study voluntarily visit the institution and sign up for their participation. As they go through pre-examination, if the participants meet inclusion criteria, their enrollment will be decided. Then, selected participants will be randomly placed to either test or placebo group; the members in these group will intake test or placebo supplement for 12 weeks |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Others (funtional food) |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Dietary Supplement |
Intervention Description | - experimental group 50 people / placebo group 50 people - intake 2 tablet / time and 1 times a day - intake for 12 weeks |
Number of Arms | 2 |
Arm 1 |
Arm Label Experimental |
Target Number of Participant 50 |
|
Arm Type Experimental |
|
Arm Description - Hordeum vulgare L. Extract 1g/day - intake 2 tablet / time and 1 times a day - intake for 12 weeks |
|
Arm 2 |
Arm Label Placebo group |
Target Number of Participant 50 |
|
Arm Type Placebo comparator |
|
Arm Description - Placebo - intake 2 tablet / time and 1 times a day - intake for 12 weeks |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified Overweighted or obesity |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~70Year |
|
Description 1) Male or female subjects aged from 19 to 70 years old 2) BMI of 25 to <30 kg/m2 3) Satisfied with 1), 2) and subjects who decided to voluntarily participate in this clinical trial and complete to sign on the informed consent |
|
Exclusion Criteria |
1) Participants with intentional weight loss of at least 10% within 3 months prior to screening 2) Subjects who have experience in influencing the interpretation of the results of this study, such as carbohydrates and lipid metabolism, drugs that can affect weight and hormones, or health functional foods within the last two months. 3) Subjects with acute severe cardiovascular disease such as heart failure, myocardial infarction, stroke, etc. 4) Subjects who in which the local or the systemic inflammatory immune disease including the rheumatoid arthritis, the autoimmune disease etc. 5) Subjects who have clinically significant hypersensitivity history due to drug, experimental product or ingredients 6) Subjects who have a medical history of gastrointestinal diseases(Crohn's disease, etc.) or operation(except appendectomy or herniotomy) 7) Participation in other clinical trials within the previous three months 8) Subjects with kidney disease, such as acute/chronic renal failure, nephrotic syndrome, etc 9) Subjects who has received antipsychotic treatment within two months before screening test 10) Subjects with reduced liver or kidney function ☞ AST, ALT > 3 times the upper limit of normal ☞ Creatinine ≥ 2.0mg/dL 11) Subjects who are suspected drug abuse or have a medical history of dependent on drug 12) Subjects who are pregnant and breastfeeding female 13) Subject who do not perform adequate contraception in the urban eligible women (except woman who undergo sterilization operation) 14) Subject with hypersensitivity to the ingredients contained in a clinical product 15) Subject who takes diabetes and diabetes drugs 16) Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg) 17) Subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Fat mass, Percent Body Fat, Lean Mass by DEXA(Dual-energy X-ray absorptiometry) Dual Energy X-ray Absorptiometry |
|
Timepoint | week 0, week 12 |
|
Secondary Outcome(s) 1 | ||
Outcome | Body weight |
|
Timepoint | screening, week 6, week 12 |
|
Secondary Outcome(s) 2 | ||
Outcome | Body mass index |
|
Timepoint | screening, week 6, week 12 |
|
Secondary Outcome(s) 3 | ||
Outcome | waist circumference, hip circumference, waist circumference/hip circumference ratio |
|
Timepoint | screening, week 6, week 12 |
|
Secondary Outcome(s) 4 | ||
Outcome | Adipokine(leptin, adiponectin) |
|
Timepoint | screening, week 6, week 12 |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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