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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic diet with caloric restriction | Experimental |
| |
| Normal diet with caloric restriction | Active Comparator |
| |
| Normal diet without caloric restriction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic diet with caloric restriction | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Baseline and after 12 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after 12 weeks of intervention |
| Change in Fasting Glucose Level |
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Inclusion Criteria:
• Males and females individuals aged 18-40 years
Exclusion Criteria:
Individuals diagnosed with any other chronic disease or type 1 and type 2 diabetes mellitus.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aseel nutrition center | Amman | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41747400 | Derived | Jawamis A, Al-Domi H, Sarayreh NA. Effects of the ketogenic-caloric restricted diet on metabolic endotoxemia and metabolic health in adults with prediabetes: A randomized controlled trial. Nutrition. 2026 Jun;146:113119. doi: 10.1016/j.nut.2026.113119. Epub 2026 Jan 23. |
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The individual participant data (IPD) will not be shared due to privacy concerns and institutional policies. Data access is restricted to the research team to ensure confidentiality and compliance with ethical guidelines.
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|
| Normal diet with caloric restriction | Other | 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. |
|
| Normal diet without caloric restriction | Other | 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. |
|
Fasting glucose will be measured to assess glycemic control before and after the dietary intervention. |
| 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. | 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." | 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. | Baseline and every 2 weeks until week 12 |
| Dietary Intake using Food Records | 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 | 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. | 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. | 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. | 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. | Baseline and every 2 weeks until week 12 |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D002149 | Energy Intake |
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