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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Participants in this group will follow a ketogenic diet with caloric restriction (-550 kcal/day), consisting of approximately 5-10% carbohydrates, 15-25% protein, 70-80% fat. The daily carbohydrate intake will be limited to less than 50g per day. The intervention will last for 12 weeks, with regular dietary monitoring and adherence checks every two weeks.
Participants in this group will follow a normal diet with caloric restriction (-550 kcal/day), consisting of approximately 45-60% carbohydrates, 15-25% protein, 20-30% fat. The intervention will last for 12 weeks, with regular dietary monitoring and adherence checks every two weeks.
Participants in this group will follow a normal diet without caloric restriction, consisting of approximately 45-60% carbohydrates, 15-25% protein, 20-30% fat. The intervention will last for 12 weeks, with regular dietary monitoring and adherence checks every two weeks.
Aseel nutrition center
Amman, Jordan
Serum Lipopolysaccharides (LPS) Levels
Serum LPS levels will be measured using ELISA before and after the dietary intervention to assess the impact of ketogenic-caloric restricted diet on metabolic endotoxemia in adult participants with obesity and insulin resistance."
Time frame: Baseline and after 12 weeks of intervention
TNF-α, IL-6 serum levels
Serum TNF-α and IL-6 levels will be measured using ELISA at baseline and after 12 weeks to assess the inflammatory response to dietary interventions.
Time frame: Baseline and after 12 weeks of intervention
Change in Fasting Glucose Level
Fasting glucose will be measured to assess glycemic control before and after the dietary intervention.
Time frame: Baseline and after 12 weeks of intervention
Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)
Lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be analyzed at baseline and post-intervention to determine the impact of dietary modifications on lipid metabolism.
Time frame: Baseline and after 12 weeks of intervention
Ketone bodies
ketone bodies will be measured to assess the adherence to ketogenic diet (just for arm 1) levels at week 6 and after 12 weeks of intervention."
Time frame: week 6 and after 12 weeks of intervention
Change in Body weight in kilograms
Body weight in kilograms will be measured using a calibrated digital scale (InBody 120) while participants are wearing light clothing and no shoes. Measurements will be taken every two weeks throughout the 12-week intervention period. The average weight will be recorded at each time point, and changes from baseline will be analyzed across intervention groups.
Time frame: Baseline and every 2 weeks until week 12
Dietary Intake using Food Records
Time frame: week4, week 8 and week 12
Change in Fasting Insulin Level
Fasting insulin will be measured to evaluate insulin levels at baseline and after 12 weeks of intervention
Time frame: Baseline and after 12 weeks of intervention
Change in HOMA-IR Index
HOMA-IR index will be calculated using fasting insulin and glucose levels to evaluate changes in insulin resistance.
Time frame: Baseline and after 12 weeks of intervention
Height in meters
Height in meters will be measured using a stadiometer with participants standing without shoes, feet flat, and head positioned in the Frankfurt plane. The measurement will be recorded to the nearest 0.1 cm. The average height will be calculated for each group at baseline and used for descriptive comparison and used for BMI calculations.
Time frame: Baseline only
Body fat percentage and lean body mass using bioelectrical impedance analysis (BIA)
Body composition, including body fat percentage and lean body mass, will be measured using a validated bioelectrical impedance analysis (BIA) device (InBody 120). Measurements will be conducted with participants fasting, at baseline and every 2 weeks during the 12-week intervention period. The mean and standard deviation for each variable will be calculated at each time point and compared between intervention groups over time.
Time frame: Baseline and every 2 weeks until week 12
Body Mass Index (BMI) in kg/m²
BMI will be calculated using the standard formula: weight (in kilograms) divided by the square of height (in meters) \[kg/m²\]. Weight and height will be measured using calibrated digital scales and stadiometers, respectively, with participants wearing light clothing and no shoes. The mean BMI will be calculated at each time point, and changes from baseline will be compared between intervention groups.
Time frame: Baseline and every 2 weeks until week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.