Agavins Impact on Gastrointestinal Tolerability-Related Symptoms during a Five-Week Dose-Escalation Intervention in Lean and Obese Mexican Adults: Exploratory Randomized Clinical Trial

Agavins are prebiotics and functional fiber that modulated the gut microbiota and metabolic status in obese mice. Here, we designed a placebo-controlled, double-blind, exploratory study to assess fluctuations in gastrointestinal (GI) tolerability-related symptoms to increasing doses of agavins in 38 lean and obese Mexican adults for five weeks and their impact on subjective appetite, satiety, metabolic markers, and body composition. All GI symptoms showed higher scores than placebo at almost every dose for both lean and obese groups. Flatulence caused an intense discomfort in the lean-agavins group at 7 g/day, while obese-agavins reported a mild-to-moderate effect for all five symptoms: no significant differences among 7, 10, and 12 g/day for flatulence, bloating, and diarrhea. Ratings for any GI symptom differed between 10 and 12 g/day in neither group. The inter-group comparison demonstrated a steady trend in GI symptoms scores in obese participants not seen for lean volunteers that could improve their adherence to larger trials. Only body weight after 10 g/day reduced from baseline conditions in obese-agavins, with changes in triglycerides and very-low-density lipoproteins compared to placebo at 5 g/day, and in total cholesterol for 10 g/day. Altogether, these results would help design future trials to evaluate agavins impact on obese adults.