Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus sakei
1 pack contained 5 x 109 cfu
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass change in 12-week | 12 weeks | fat mass is measured by DEXA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body weight | 12 weeks | body weight change |
| Changes in waist circumference | 12 weeks | Waist circumference change |
| Glucose metabolism | 12 weeks | Changes in HbA1c |
Other
| Measure | Time frame | Description |
|---|---|---|
| GI adverse effect | 12 weeks | incidence of gastrointestinal discomfort |
Countries
South Korea
Outcome results
None listed