Study Evaluating Effects of Different Amounts and Forms of Sucrose and Sucralose on Metabolism in Adults with Normal Weight, Overweight, or Obesity

What this Trial Is About

This research aims to evaluate how adding two common sweeteners, sucrose table sugar and sucralose a low-calorie sweetener, at low and high doses affects glucose regulation, including insulin resistance and fasting plasma glucose, in adults aged 18 to 65 years with normal weight, overweight, or obesity. The study also explores how sweetener type, dose, and form of consumption impact body composition, blood pressure, gut microbiota, DNA methylation, inflammation, oxidative stress, and metabolomic profiles. Participants will consume assigned amounts of either sucrose or sucralose incorporated into their usual foods or beverages, maintaining their normal diet and calorie intake. The study includes two consecutive 12-week intervention phases, one with solid foods and the other with liquids, separated by a two-week washout period. Doses for sucrose are calculated as 5% or 10% of estimated energy needs, while sucralose is given as 5 or 10 tablets daily, maintaining a 12 dose ratio between low and high doses. During the study, participants attend scheduled visits for body measurements, dietary assessments, and collection of blood, urine, and stool samples before and after each intervention phase. Researchers will measure changes in insulin resistance HOMA-IR, fasting glucose, body fat, blood pressure, biochemical markers, gut microbiota, DNA methylation in blood cells, and biomarkers related to inflammation and metabolism. The total participation period includes the run-in, intervention, and washout phases.

SucroMet Nutritional Intervention Trial