source: https://uat.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383901
Abstract
Intervention: 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 7×10^10 CFU Lactobacillus plantarum 299v (DSM9843), 5×10^9 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 suicient 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.
Condition: Diet and Nutrition – Obesity Obesity; ; Obesity
Primary outcome: Changes of inflammatory parameters (interleukin-6, interleukin-17, tumor necrosis factor-alpha, C-reactive protein)-serum/plasma assay[90 days aer intervention commencement] Change of anthropometric parameters:; body weight – using scale with bioelectrical impedance analysis technology; body height- using stadiometer; body mass index – using scale with bioelectrical impedance analysis technology; waist and hip circumference – using a tape measure[90 days aer intervention commencement] Changes of biochemical parameters (lipid status, glucose, hemoglobin A1c and insulin levels) – serum/plasma assay[90 days aer intervention commencement]
Secondary outcome: Changes in the composition of the fecal microbiota – feces assay[90 days aer intervention commencement] changes in epigenetics – PCR (blood sample)[90 days aer intervention commencement] changes in dietary habits – 72-hour dietary recall questionnaire[90 days aer intervention commencement] leukocyte typing – flow cytometry (serum/plasma assay)[90 days aer intervention commencement] side eects – adverse events were assessed by interviews with participants at the end of intervention period, and they were recorded on the adverse event form throughout the study. The participants were asked to self-report any health-related problems or symptoms they were experiencing during the intervention period.[90 days aer intervention commencement]
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)