A Novel Fasting Mimetic (Mimio) Improves Hunger, Digestion, Oxidative Stress, and Cardiometabolic Markers in Overweight Adults with Elevated HbA1c: a Double-Blind, Randomized, Placebo-Controlled Trial

This decentralized, double-blind, randomized, placebo-controlled trial investigated the impact of a novel fasting mimetic "Mimio" on hunger, satiety, digestive symptoms, metabolism, cognition and wellbeing in overweight older adults with elevated HbA1c. Participants collected 2 weeks of baseline subjective data along with a fasted metabolic blood panel. The Mimio fasting mimetic, containing spermidine, nicotinamide, palmitoylethanolamide (PEA) and oleoethanolamide (OEA), or a placebo capsule was then taken before the first meal of the day for 8 weeks. Subjective measures were repeatedly collected throughout the study and metabolic bloodwork was repeated at the end of 8 weeks. 42 Participants were evaluated (47.6% female, BMI 27.6 (0.2) kg/m2, aged 62 {+/-} 4, HbA1c 6.0 {+/-} 0.1, n=23 intervention and n=19 placebo). Mimio improved more over time in all hunger and satiety metrics than placebo (Hunger and Satiety Composite Score Mann-Kendall p=2.2*10-16). More participants in the Mimio group improved daily ratings of hunger and appetite compared to placebo, including 91% vs. 47% of participants improving mealtime appetite across the study (Fishers Exact Test p=0.003). The Mimio cohort reported significantly less abdominal pain and bloating than the placebo group (Mann-Whitney U p<0.05). Mimio significantly reduced total cholesterol, LDL cholesterol, LDL particle number, oxidized LDL, non-HDL cholesterol and fasting glucose compared to placebo (Mann-Whitney U p<0.05). Changes in quality of life, three-factor eating questionnaire and cognitive failures did not differ significantly between Mimio and placebo. There were no significant differences in any adverse effects between Mimio and placebo. Mimio, a daily fasting mimetic supplement, improves daily hunger and satiety, reduces oxidative stress, symptoms of indigestion and improves cardiometabolic health markers in overweight older adults with elevated HbA1c. This is the first study to show that fasting mimetic supplementation can recreate clinical fasting-like cardiometabolic benefits without lifestyle changes or the need to fast. Trial RegistrationThe trial was IRB approved and registered with ClinicalTrials.gov (Pro00080269).