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A 12-week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of LB-P5 (prpbiotics) on reducing body fat

A 12-week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of LB-P5 on reducing body fat

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010357
Enrollment
120
Registered
2025-03-28
Start date
2024-03-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

None listed

Interventions

Dietary Supplement : 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 se

Sponsors

LISCure Biosciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults, both male and female, aged between 19 and 65 years as of the date of written consent. 2) Individuals with a Body Mass Index (BMI) of 25 kg/m² to less than 30 kg/m² 3) A person who voluntarily agrees to participate in the study and signs an informed consent form for the study

Exclusion criteria

Exclusion criteria: 1) Those currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary systems, kidneys and urinary systems, nervous system, mental, musculoskeletal, infectious diseases, malignant tumors, etc. (However, considering the condition of the test subject, You can participate in the test at your discretion) 2) Those who have undergone obesity surgery (gastric bandoplasty, sleeve gastrectomy, gastric bypass surgery, etc.) within 1 year as of visit 1 3) Those who used the following drugs (or foods) within 1 month (30 days) of visit 1 ? Obesity treatment drugs (appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.) ? Psychiatric drugs such as depression and schizophrenia ? Beta blockers, diuretics, steroids (sex hormones, corticosteroids), contraceptives, thyroid hormones, hormone blockers, immunosuppressants, proton pump inhibitors ? Hyperlipidemia drugs, health functional foods that improve blood lipids and cholesterol {Omega 3 (oils containing EPA and DHA), indigestible maltodextrin, fats and oils containing gamma-linolenic acid, lecithin, plant sterols, etc.} ? Health functional foods/supplements for weight control purposes, herbal medicine, and weight control formulated foods 4) Those who have taken antibiotics or antiseptics within 2 weeks of visit 1 5) Those who consumed probiotics, prebiotics, synbiotics, fermented milk, and lactic acid bacteria products continuously (more than 4 times a week) that can help increase intestinal beneficial bacteria, improve bowel movements, and reduce body fat within 2 weeks of visit 1 6) Those who started rapid exercise within 3 months before the start of the test or at the same time as the start of the test 7) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest) 8) Diabetic patients whose fasting blood sugar level is 126 mg/dL or higher or who are taking antidiabetic agents (oral hypoglycemic agents, insulin, etc.) 9) Those whose TSH is outside the normal range of the implementing agency 10) Those with an eGFR of less than 60 mL/min/1.73 m2 11) Those whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of normal at the implementing institution 12) Those with a history of alcohol abuse or those who chronically consume alcohol *More than 40 g/day (280 g/week) for men, and more than 20 g/day (140 g/week) for women 13) Heavy smokers (more than 20 cigarettes/day) 14) Those who are judged to be unable to exercise due to musculoskeletal disease 15) Those who have had a weight change of more than 10% or more than 5 kg within 3 months from visit 1 16) Those who participated in a commercial obesity program within 3 months of visit 1 17) Those who gave birth within 6 months of visit 1, are pregnant or lactating, or plan to become pregnant during this human application trial period. 18) Persons who have problems consuming food for human application testing due to severe gastrointestinal disorders 19) Those who have participated in other interventional clinical trials (including human trials) within 3 months as of visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial 20) Those who are sensitive or allergic to the food ingredients for this human application test 21) A person who is deemed unsuitable by the investigator for o

Design outcomes

Primary

MeasureTime frame
Body fat mass measured by DEXA

Secondary

MeasureTime frame
Body fat percentage by DEXA;Lean mass by DEXA;Weight, Body Mass Index (BMI);Waist circumference, Hip circumference, Waist/Hip ratio, thigh circumference, arm circumference;Visceral fat area, Subcutaneous fat area, Total abdominal fat area, Visceral/Subcutaneous fat area ratio by CT;Blood Liqids : Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglyceride;Adiponectin, Leptin

Countries

Korea, Republic of

Contacts

Public ContactCHAE MIN BAEG

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