Clinical Research Directory

Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia

Sponsor: Genbioma Aplicaciones SL

Summary

This study will evaluate the effects of pA1c®HI, a heat-inactivated postbiotic derived from the bacterium Pediococcus acidilactici, on blood glucose regulation and other aspects of metabolic health in adults with elevated blood glucose levels who do not have diagnosed diabetes. The study will include approximately 100 adults aged 18 to 80 years with glycated hemoglobin (HbA1c) levels of 5.7% to less than 6.5%, a range consistent with prediabetes. A postbiotic is a preparation of inactivated microorganisms and/or their components that may provide health benefits. pA1c®HI does not contain live bacteria. This is an open-label, single-group study. All participants will take one capsule of pA1c®HI daily for 12 weeks. There is no placebo or separate control group. Researchers will compare measurements taken before and after the intervention to assess changes over time. Participants will continue their usual medical care and previously established lifestyle recommendations. The study will include assessments at the beginning and end of the intervention. These will include blood tests, measurements of body weight and other physical characteristics, questionnaires, and continuous glucose monitoring for 14 days at each assessment period. Participants will also provide stool samples for analysis of gut microbiota composition. Blood tests will assess glycated hemoglobin, fasting glucose, insulin-related markers, blood lipids, liver function, and other parameters. Researchers will also measure glucagon-like peptide-1 (GLP-1), a hormone involved in blood glucose regulation, including its response to a mixed meal. The main objective is to evaluate changes in HbA1c after 12 weeks of daily pA1c®HI supplementation. Other objectives include assessing changes in glucose levels and variability, insulin resistance markers, blood lipids, GLP-1 responses, gut microbiota composition, and body measurements. The study will also assess adherence to supplementation and monitor safety and tolerability. The findings will help researchers understand the potential effects of pA1c®HI on metabolic health in adults with elevated blood glucose levels. Because the study does not include a placebo or control group, changes observed during the study cannot be attributed to the postbiotic with the same certainty as in a controlled trial.

Official title: A Study of the Efficacy of the Postbiotic pA1c®HI as a Metabolic Regulator in Healthy Individuals With Hyperglycemia

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