Effects of multi-strain probiotics supplementation on body adiposity and metabolic profile in individuals with hypertension and overweight following an energy-restricted diet: A randomized clinical trial.

BACKGROUND & AIMS: Recent evidence suggests that gut microbiota has a potential role in the pathophysiology of obesity and other cardiovascular disease (CVD) risk factors, including hypertension, dyslipidemia, and type 2 diabetes. However, clinical trials evaluating the effects of probiotics supplementation on these outcomes have found inconsistent results, probably due to the wide heterogeneity in trial designs. In addition, there is a lack of studies investigating whether probiotics can enhance the beneficial effects of caloric restriction in individuals with increased risk of CVD as individuals with hypertension and excess body adiposity. Thus, the aim of this study was to evaluate the effects of multi-strain probiotics supplementation on body adiposity, glycemic homeostasis, lipid profile, and serum adipokine levels in individuals with hypertension and excess body weight following an energy restricted diet.

METHODS

A randomized, double-blind, placebo controlled clinical trial was conducted for 12 weeks. Were included 66 individuals aged between 40 and 65 years; both sexes; body mass index (BMI) ≥ 25 and < 40 kg/m and diagnosis of hypertension. Were excluded smokers; individuals using probiotics, prebiotics, symbiotics and antibiotics in the last 3 months; presenting diabetes, chronic kidney disease or liver failure; and pregnant and lactating women. Participants were allocated into 2 groups: group with supplementation of 8 probiotic strains in capsules (3 × 10 CFU/day) or control group (placebo capsules). Both groups followed a low-calorie diet. Participants underwent anthropometric, body composition (dual-energy radiological absorptiometry) and biochemical (glucose metabolism, lipid profile, adiponectin, and leptin) evaluation at baseline and at the end of the study.

RESULTS

After 12 weeks of intervention, the probiotics group presented: a) reduction of body weight, BMI, circumferences of waist, hip and neck and waist-to-height ratio; b) decrease in total fat mass (kg); and c) reduction of glycated hemoglobin (HbA1c). In the control group, it was observed: a) significant reduction in all anthropometric variables; b) significant reduction in total fat mass (kg and %), trunk fat mass (kg), visceral fat and load capacity index. In the comparison between groups, there was a higher decrease in HbA1c in the probiotics group (p < 0.05).

CONCLUSION

Multi-strain probiotics supplementation associated with energy restriction in individuals with excess body weight and hypertension promoted a significant improvement in glucose homeostasis assessed by HbA1c. The clinical trial was registered at www.ensaiosclinicos.gov.br: RBR-7jw4ry.