Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Weight (values expressed in kg measured with digital weighing scale). Measurement Time: At baseline and, 12 weeks.
Key secondary outcomes:
1- Body composition (Body fat (values expressed in g/cm2 measured with densimeter LUNAR Prodigy); lean mass (values expressed in g/cm2 measured with densimeter LUNAR Prodigy); bone mass (values expressed in g/cm2 measured with densimeter LUNAR Prodigy); bioimpedance (values expressed in % of fat measured with InBody770)). Measurement Time: At baseline and, 12 weeks.
2- Gut microbiome (gut microbiome composition (values expressed as abundance of 16S rRNA gene fragments obtained from sequencing the variable V4 region with Illumina MiSeq technology)). Measurement Time: At baseline and, 12 weeks.
3- Biochemical markers (Total cholesterol in plasma (values expressed in mg/dL determined by enzymatic assay of oxidized glucose; cholesterol LDL, HDL (values expressed in mg/dL determined by direct enzymatic method); triglycerides (values expressed in mg/dL determined by the enzymatic colorimetric test, Roche, Mannheim, Germany); glycemia (values expressed in mg/dL determined by enzymatic assay); fasting insulin (values expressed in µUI/mL measured by a chemo-luminescence immunoassay); glycosylated hemoglobin (values expressed in mmol/mol measured with HPLC, Premier Hb9210; Lab Care, UK); C-reactive protein (values expressed in mg/dL determined by immunoturbidimetric high-sensitivity assay, Roche Diagnostics Mannheim, Germany, Hitachi 902); IL-18 (values expressed in ng/mL measured by multianalyte immunoassay using xMAP from Luminex and reads obtained from multi analyzer Magpix, Luminex Corp., USA); Chemerin (values expressed in ng/mL measured by multianalyte immunoassay using xMAP from Luminex and reads obtained from multi analyzer Magpix, Luminex Corp., USA); LBP in plasma (values expressed in ng/mL measured by multianalyte immunoassay using xMAP from Luminex and reads obtained from multi analyzer Magpix, Luminex Corp., USA); oxysterols (values expressed in mg/dL measured with GC/MS); short fatty acids in plasma (values expressed in mg/dL measured with GC/MS); Peptides: AgRP/ART, adiponectin, leptin (values expressed in ng/mL measured by multianalyte immunoassay using xMAP from Luminex and reads obtained from multi analyzer Magpix, Luminex Corp., USA)). Measurement Time: At baseline and, 12 weeks.
4- Food consumption (values expressed in g recorded as 24-hour reminder format). Measurement Time: At baseline and 3, 6, and 12 weeks.
5- Blood pressure (values expressed in mm Hg measured with blood pressure monitor). Measurement Time: At baseline and, 12 weeks.