Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
Not Applicable
Completed
- Conditions
- Obesity
- Interventions
- Dietary Supplement: Lactobacillus sakei
- Registration Number
- NCT03248414
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.
- Detailed Description
We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
- age 20-65 years
- BMI equal to higher than 25 kg/m2
Exclusion Criteria
- under anti-obesity medication
- uncontrolled diabetes
- uncontrolled hypertension
- any medications can influence to body weight such as thiazolidinedione, GLP-1 analogue, SGLT2 inhibitor, diuretics
- thyroid function test abnormality
- malignancy within 5 years
- immune compromised hosts or under immune suppressants
- antibiotics or probiotics withing 2 weeks
- any intervention to reduce body weight within 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Lactobacillus sakei 2 packs per day Lactobacillus sakei Lactobacillus sakei 2 packs per day
- Primary Outcome Measures
Name Time Method Fat mass change in 12-week 12 weeks fat mass is measured by DEXA
- Secondary Outcome Measures
Name Time Method Changes in body weight 12 weeks body weight change
Changes in waist circumference 12 weeks Waist circumference change
Glucose metabolism 12 weeks Changes in beta-cell function
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi, Korea, Republic of