The Effect of Ketogenic-caloric Restricted Diet on Metabolic Endotoxemia in Prediabetic Obese Adults

Insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. Metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (LPS), disrupts insulin signaling via inflammatory pathways. While dietary interventions may lower LPS levels and improve insulin resistance, evidence on the effectiveness of ketogenic diet in this context remains limited. This randomized controlled trial aims to assess the effects of a ketogenic-caloric restricted diet on metabolic endotoxemia, measured by serum LPS levels, in prediabetic obese Jordanian adults aged 18-40 years in Amman over 12 weeks. Ninety participants will be randomly assigned to one of three groups (n=30 each): a ketogenic-caloric restricted diet, a normal-fat caloric restricted diet, or a control group (normal-fat without caloric restriction). Anthropometric parameters and dietary intake will be evaluated at baseline, week 6, and week 12. Blood samples will be collected at baseline and week 12 for measuring fasting glucose, insulin, LPS, inflammatory cytokines. Dietary adherence will be monitored through food records. This study aims to provide new insights into the role of dietary interventions in modifying metabolic endotoxemia and improving insulin resistance.

NCT Number	NCT06911879
Lead Sponsor	University of Jordan
Conditions	Insulin Resistance, Metabolic Endotoxemia, Inflammation Biomarkers, Ketogenic Diet, Caloric Restriction, Obesity, Prediabetes
Enrollment	90 participants
Start Date	2025-05-05
Primary Completion	2025-08-05 (estimated)
Study Completion	2025-08-05 (estimated)
Updated on ClinicalTrials.gov	2026-05-05