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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248414
• Other study ID #: B-1511/324-002
• Status: Completed
• Phase: N/A
• Start date: August 10, 2016
• Est. completion date: September 10, 2018

Study information

• Verified date: September 2018
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 10, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Lactobacillus sakei
1 pack contained 5 x 109 cfu

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	GI adverse effect	incidence of gastrointestinal discomfort	12 weeks
Primary	Fat mass change in 12-week	fat mass is measured by DEXA	12 weeks
Secondary	Changes in body weight	body weight change	12 weeks
Secondary	Changes in waist circumference	Waist circumference change	12 weeks
Secondary	Glucose metabolism	Changes in HbA1c	12 weeks
Secondary	Glucose metabolism	Changes in fasting glucose concentration	12 weeks
Secondary	Glucose metabolism	Changes in insulin resistance	12 weeks
Secondary	Glucose metabolism	Changes in beta-cell function	12 weeks