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

Launched by UNIVERSITY OF JORDAN · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a special diet called a ketogenic-caloric restricted diet affects certain health markers in people who are prediabetic and obese. Researchers want to see if this diet can lower levels of a substance in the blood called lipopolysaccharides (LPS), which is linked to insulin resistance—a condition that can lead to type 2 diabetes and heart disease. The trial will include 90 adults aged 18-40 years in Amman, Jordan, and will last for 12 weeks. Participants will be divided into three groups: one will follow the ketogenic diet, another will follow a normal-fat diet with fewer calories, and the third group will not change their diet at all.

To be eligible, participants must be between 18 and 40 years old, have a body mass index (BMI) between 30 and 40 (indicating obesity), and have been diagnosed with prediabetes by a doctor. They should also be willing to stick to the dietary plan and not currently be active in sports. Throughout the trial, participants will have their weight and eating habits monitored, and blood tests will be done to check levels of glucose, insulin, and inflammation markers at the beginning and end of the study. This research aims to better understand how diet can impact metabolic health and insulin resistance, which could lead to better ways to prevent diabetes and related health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Males and females individuals aged 18-40 years
• • Individuals with a body mass index (BMI) greater than 30 kg/m² and less than 40 kg/m².
• • Individuals medically diagnosed with prediabetes by a physician prior to enrollment in the study as indicated by hemoglobin A1c (HbA1c) levels between 5.7% and 6.4% (American Diabetes Association, 2024), or HOMA-IR score of greater than 1.8.
• • Individuals demonstrating a willingness to follow the dietary protocol
• • Individuals engaging in sedentary physical activity levels
• Exclusion Criteria:
• • Individuals diagnosed with any other chronic disease or type 1 and type 2 diabetes mellitus.
• • Individuals have experienced weight loss of more than 5% in the last three months.
• • Pregnant or lactating women.
• • Individuals undergoing any form of drug treatment.
• • Individuals with a history of major surgery.
• • Individuals have consumed pro-/pre/symbiotic or antibiotics in the past three months.
• • Individuals who engage in any form of regular sports activity.