A Clinical Trial for the Evaluation of the Efficacy and Safety of MED-02 Probiotics on Reducing Body Fat

A 12 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MED-02 Probiotics on Reducing Body Fat

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0005861

Enrollment

100

Registered

2021-02-03

Start date

2020-12-01

Completion date

Unknown

Last updated

2021-02-23

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 : Intervention group: MED-02 probiotics 500mg capsule once a day Placebo group: placebo 500mg capsule once a day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: 19-65 Body mass index: 25~32 A person who agrees to participate in this human application test and writes a written consent

Exclusion criteria

Exclusion criteria: Those who are currently being treated for severe cardiovascular, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, psychotic, infectious disease and malignant tumor Those who use drugs that affect weight, health functional foods for weight control purposes, herbal medicines, or weight control formulas Those who administered antibiotics within 2 weeks Those who have consumed probiotics or lactobacillus products continuously within 2 weeks Patients with uncontrolled hypertension Diabetic patients with fasting blood sugar of 126 mg/dl or more or taking antidiabetic drugs Those whose TSH is less than 0.1 uIU/ml or more than 10 uIU/ml Those whose Creatinine is more than twice the normal upper limit Those whose AST/ALT is more than 3 times the normal upper limit Those who have problems in eating food for human application due to severe gastrointestinal disorders People with alcohol use disorder and/or CNS disorder Those who are judged to be unable to exercise due to musculoskeletal disorders Those who have had a weight change of 10% or more within 3 months Those who participated in a commercial obesity program within 3 months Those who have participated in other interventional clinical trials within one month or plan to participate in other interventional clinical trials Pregnant, nursing or planning to become pregnant A person who judges that the tester is inappropriate for other reasons

Design outcomes

Primary

Measure	Time frame
Body fat mass;body fat percentage	—

Secondary

Measure	Time frame
Body weight, Waist circumference, Hip circumference, WHR, BMI, Lean body mass, Visceral fat area, Subcutaneous fat area, total abdominal fat area, VSR;Total cholesterol/HDL cholesterol/LDL cholesterol/Triglyceride/hs-CRP/Adiponectin/Leptin	—

Countries

Korea, Republic of

Contacts

Public ContactYOUNGGYU CHO

Inje University Seoul Paik Hospital

Outcome results