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A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EEIP on Reducing Body Fat

A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EEIP on Reducing Body Fat

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008259
Enrollment
120
Registered
2023-03-06
Start date
2022-07-13
Completion date
Unknown
Last updated
2023-04-04

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

Conditions

None listed

Interventions

Others : Targeting human application test subjects who voluntarily signed the Informed Consent Form for human application test, a visit evaluation was conducted to determine whether the selection/excl

Sponsors

COSMAX BIO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those who are over 19 years old and under 65 years old 2) Those with a body mass index (BMI) of 25 kg/m 2 or more and less than 32 kg/m 2 on visit 1 and visit 2 3) A person who agreed to participate in this human application test and filled out the written consent (Informed Consent Form) before the human application test started

Exclusion criteria

Exclusion criteria: 1) Those currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary tract, kidney and urinary, nervous, psychiatric, infectious diseases and malignant tumors (however, considering the condition of the test subject, You can participate in the test at your discretion.) 2) Persons with alcohol use or induced disorders or central nervous disorders 3) Those who are judged to be unable to exercise due to musculoskeletal disorders 4) Drugs that affect weight within 1 month (30 days) of visit 1 {anti-obesity drugs (appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.), psychiatric drugs such as depression and schizophrenia, beta-blockers, Those who use diuretics, contraceptives, steroids, female hormones, thyroid hormones}, health functional foods/supplements for weight control purposes, herbal medicines, and weight control formulas 5) Subjects who have taken hyperlipidemia drugs within 1 month (30 days) of visit 1 or who have taken omega 3 within 2 weeks of visit 1 6) A person who has had a weight change of 10% or more within 3 months from visit 1 7) Those who participated in a commercial obesity program within 3 months of visit 1 8) A person whose creatinine is more than twice the upper limit of normal at the implementing institution 9) A person whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of normal 10) Uncontrolled hypertension patients (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more, measurement criteria after subject resting for 10 minutes) 11) Diabetic patients with a fasting blood sugar of 126 mg/dL or higher or taking anti-diabetic drugs (oral hypoglycemic agents, insulin, etc.) 12) Those whose TSH is less than 0.1 µIU/mL or more than 10 µIU/mL 13) Those who have participated in other interventional clinical trials (including human trials) within 3 months of visit 1, or plan to participate in other interventional clinical trials (including human trials) after the start of this human trial 14) Pregnant or lactating women or those who plan to become pregnant during this human application test 15) Those who are sensitive or allergic to food ingredients for this human application test 16) Those who are judged unsuitable by the tester for other reasons

Design outcomes

Primary

MeasureTime frame
Body fat mass and body fat percentage through DEXA

Secondary

MeasureTime frame
Weight;Body Mass Index(BMI);Waist circumference, Hip circumference, Waist/Hip ratio;Lean mass and Skeletal muscle through DEXA;Visceral fat area, Subcutaneous fat area, Total abdominal fat area, Visceral/Subcutaneous fat area ratio through CT;Blood Liqids: Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;hs-CRP;Leptin, LPL

Countries

Korea, Republic of

Contacts

Public ContactCHAEMIN BAEK

Global Medical Research Center

chamin38@gmail.com+82-70-8801-7080

Outcome results

None listed

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