Pilot Study to Test the Effects of Oral AM3 and Probiotic Supplements on Inflammation and Metabolic Health in Adults With Metabolic Syndrome

What this Trial Is About

Researchers are studying the effects of a nutritional supplement combining AM3 technology and probiotics on adults diagnosed with metabolic syndrome. This pilot study aims to understand how this supplementation influences inflammatory and metabolic factors that contribute to chronic conditions linked to metabolic syndrome. A total of 48 participants aged 18 to 75 years with metabolic syndrome will be enrolled and randomly assigned to different treatment groups. Participants are divided into three groups one receiving AM3 combined with the probiotic SynBalance Metsyn, one receiving a placebo of starch capsules, and one receiving AM3 capsules alone without probiotics. Each participant will take two capsules once daily in the morning for 12 weeks. The study is double-blind and placebo-controlled, with two main visits scheduled at the start and at the end of the 12-week treatment period. During the study, researchers will collect various health measurements including body composition weight, BMI, blood pressure, blood glucose, insulin levels, immune cell populations, liver enzymes, and urine analysis. Participants will also complete quality of life questionnaires before and after treatment. The primary outcome is the change in serum cytokines measured at baseline and week 12. Secondary outcomes include changes in metabolic markers, body measurements, and quality of life. The study follows participants for 12 weeks of treatment from baseline to final evaluation.

A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.