OBJECTIVE: this trial aimed to determine the effects of probiotic supplementation on weight loss and lipid profiles in hypercholesterolemic obese patients. METHODS: ın this pilot randomized, double-blind, placebo-controlled trial, hypercholesterolemic obese patients (BMI = 30.0-35.0 kg/m2) were randomly divided into 2 groups to receive either probiotic capsules (n = 12) or a matching placebo (n = 12) groups. The patients in the probiotic group took capsules 2 times a day that contained Enterococcus faecium, Lactobacillus plantarum, Streptococcus thermophiles, Bifidobacterium lactis, Lactobacillus acidophilus, Bifidobacterium longum (1.5 × 109 CFU/g) for 8 weeks. All patients adhered to a medical nutrition therapy that aimed for a weight loss of 0.5 to 1 kg per week. Anthropometric measurements and body composition were taken at baseline and were monitored every week throughout the study. Blood lipids were assessed at baseline and after the 8-week intervention. RESULTS: after the 8-week dietary intervention, both probiotic and placebo groups showed significant decreased in total cholesterol (-36.50 ± 19.27 vs -25.91 ± 19.25, mg/dl), LDL-C (-(31.75 ± 18.11 vs -31.91 ± 31.00 mg/dl) and TG (-31.83 ± 67.37 vs -28.25 ± 59.09), respectively (p <
0.05). Body weight, BMI, body fat ratio, and waist circumference also significantly decreased after the dietary intervention in both groups (p <
0.05). Overall, no significant difference was found neither in the reductions of total cholesterol, LDL-C, TG concentrations nor the anthropometric indices between the probiotic and placebo groups (p >
0.05). CONCLUSIONS: the results of our study demonstrated that the administration of probiotic supplements for 8 weeks in obese subjects with hypercholesterolemia had favorable effects on lipid profiles, although there was no beneficial effect compared to the control group. These results indicate that anthropometric indices significantly decreased in response to adherence to the low-calorie diet recommended by dietitians in both the groups. However, conducting more trails with large sample size and longer follow-up time is necessary.