Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects

Seoul National University

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Lactobacillus sakei

Study type: Interventional

Funder types: Other

Identifiers

NCT03248414

B-1511/324-002

Details and patient eligibility

About

In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups, including a placebo group

Lactobacillus sakei

Experimental group

Description:

2 packs per day

Treatment:

Dietary Supplement: Lactobacillus sakei

Control

Placebo Comparator group

Description:

2 packs per day

Treatment:

Dietary Supplement: Lactobacillus sakei