Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Live and Heat Treated Bacteria Strain on Body Composition in Overweight Individuals
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Change in visceral fat area
Study Overview
Brief Summary
Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.
Detailed Description
This study aims to investigate the safety and efficacy of live and heat treated bacteria on body composition of overweight individuals. The trial will be run in a single research centre and will recruit adult men and women, with BMI of 25-33kg/m2 with abdominal obesity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body mass index 25-33kg/m2
- •Abdominal obesity (female waist circumference>85cm; male waist circumference>90cm)
- •written informed consent
Exclusion Criteria
- •Taking the following medication within 1 month before starting the study: appetite stimulants/suppressants, lipid lowering drug, contraceptive
- •taking antibiotics within 2 months before starting the study
- •secondary obesity or secondary hypertension, diabetes type 1, GI disease, dyslipidaemia, type 2diabetes, hypertension
- •consumption of pre- and probiotic-enriched products or dietary supplement for at least 4 weeks prior to the first screening visit
- •nicotine, drug or alcohol abuse,
- •other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit or confound the Study's results
Arms & Interventions
Postbiotic
Heat treated bacteria strain in a form of a capsule daily for 16 weeks
Intervention: Postbiotic (Dietary Supplement)
Placebo
Placebo in a form of a capsule administered for 16 weeks
Intervention: Placebo (Other)
Probiotic
Live bacteria strain in a form of a capsule daily for 16 weeks
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
Change in visceral fat area
Time Frame: From week 0 to Week 16
Difference in visceral fat area (cm\^2) measured using CT from week 0 to week 16
Secondary Outcomes
- Change in waist circumference(Week 0, Week 12, Week 16)
- Change in serum insulin concentration(Week 0, Week 16)
- Change in peripheral blood cholesterol(Week 0, Week 16)
- Microbiome analysis(Week 0, Week 16)
- Change in peripheral blood glucose(Week 0, Week 16)
- Change in plasma leptin levels(Week 0, Week 16)
- Change in body weight(Week 0, Week 12, Week 16)
- Change in body fat composition(Week 0, Week 12, Week 16)
- Dietary survey(Week 0, Week 16)
- Mood questionnaire(Week 0, Week 16)