None listed
Conditions
Brief summary
Numerous studies have shown that obesity may be associated with changes in the bacterial flora in the gut and that the composition of the intestinal microbiota differs in obese and normally weight individuals. Therefore, the use of dietary supplements with beneficial cultures of microorganisms, probiotics, and biologically active compounds, such as octacosanol, are increasingly considered a rational choice as part of dietary interventions in the treatment of obesity. Our study intends to evaluate the impact of a combination of two probiotic strains and octacosanol in overweight and obese women in the reproductive age. This study will be conducted as a randomized, double-blind, placebo-controlled study, where patients are going to be divided in two groups: the first group of patients (intervention group) will receive 1 oral capsule once a day for 3 months containing 7x10^10 CFU Lactobacillus plantarum 299v (DSM9843), 5x10^9 CFU Saccharomyces cerevisiae var. boulardii and 40 mg octacosanol, and another group of patients (control group) who will receive 1 oral capsule once a day for 3 months containing placebo. The aim of this study is to assess the effect of probiotics and octacosanol on anthropometric parameters, biochemical parameters (lipid status, glucose level, etc.), inflammatory parameters, epigenetics, changes in intestinal microbiota, as well as the effect on changes in the immune system (leukocyte typing), in overweight and obese women.
Interventions
The study will be conducted as a randomized, double-blind, placebo-controlled study. Intervention group will receive 1 oral capsule once a day for 3 months containing 7x10^10 CFU Lactobacillus plantarum 299v (DSM9843), 5x10^9 CFU Saccharomyces cerevisiae var. boulardii and 40 mg octacosanol.
Patients will be given dietary supplement by the Master of pharmacy, at the beginning of the study, in the form of oral capsules, which will contain listed probiotic strains and octacosanol, in an amount su
The study will be conducted as a randomized, double-blind, placebo-controlled study. Intervention group will receive 1 oral capsule once a day for 3 months containing 7x10^10 CFU Lactobacillus plantarum 299v (DSM9843), 5x10^9 CFU Saccharomyces cerevisiae var. boulardii and 40 mg octacosanol. Patients will be given dietary supplement by the Master of pharmacy, at the beginning of the study, in the form of oral capsules, which will contain listed probiotic strains and octacosanol, in an amount sufficient for 3 months (90 capsules). Patients will take dietary supplements at their home. Adherence to the intervention will be monitored by the number of returned capsules.
Sponsors
Faculty of Pharmacy, University of Belgrade
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Overweight and obese women (body mass index > 25 kg/m^2) with or without other comorbidities (hypertension, dyslipidemia,hyperglycemia and/or insulin resistance)
Exclusion criteria
Chronic disease of the kidneys, thyroid gland and gastrointestinal tract (Crohn's disease, ulcerative colitis) Taking antibiotic therapy in the last month Age under 18 years Taking probiotic and/or prebiotic dietary supplements Hypersensitivity/intolerance to any ingredient of the product Pregnancy or breast-feeding
Outcome results
None listed