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Human trial study to evaluate the efficacy and safety of TZ-HVP on decrement of body fat

A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of TZ-HVP on decrement of body fat

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005883
Enrollment
100
Registered
2021-02-10
Start date
2021-02-22
Completion date
Unknown
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

Teazen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

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

Design outcomes

Primary

MeasureTime frame
Fat mass, Percent Body Fat, Lean Mass by DEXA(Dual-energy X-ray absorptiometry) Dual Energy X-ray Absorptiometry

Secondary

MeasureTime frame
Body weight;Body mass index;waist circumference, hip circumference, waist circumference/hip circumference ratio;Adipokine(leptin, adiponectin)

Countries

Korea, Republic of

Contacts

Public ContactGwak` young

BioFoods Story

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026