2.1. Participants
chronic gastrointestinal disorders, liver or kidney diseases, inflammatory bowel disease
CELIAC, INFLAMMATORY BOWEL DISEASE, EVENT, DISEASE, TYPE 2 DIABETES MELLITUS, NEOPLASTIC DISEASE
The study employed a two-arm, parallel group, double-blinded, randomised controlled trial with 60 participants recruited between 9 March 2021 and 11 August 2022. The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Human Research Ethics Committee of The University of Adelaide (protocol code H-2020-248 on 17 November 2020) and registered on Participants were excluded if they reported any of the following: weight change >5% fluctuation in their body weight for 6 months before study entry; personal history of bariatric surgery; diagnosis of type 1 or type 2 diabetes mellitus, liver or kidney diseases, neoplastic disease in the previous three years, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac), cardiovascular event in the previous 6 months, biochemical abnormalities or evidence at screening of disease including elevated liver enzymes ALT and/or AST >3 times normal range limit; current or recent (within 12 months) treatment with medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues [i.e., exenatide], thiazolidinediones or DPP-IV inhibitors [i.e., ‘gliptins’]), medications affecting weight, appetite or gut motility (i.e., domperidone, cisapride, orlistat, phentermine, topiramate); women planning pregnancy during the course of the study or three months after completion of the study, or who were lactating; and conditions that could interfere with the ability to understand the requirements of the study. Participants who were taking stable doses (i.e., >12 months) of androgenic medications (i.e., testosterone), thyroxine, anti-depressants (selective serotonin reuptake inhibitors), anti-hypertensives (ace-inhibitors, calcium channel blockers, beta-blockers, diuretics) and lipid-lowering medications (statins, fibrates) were not excluded.