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

Not Applicable

Not yet recruiting

• Conditions: Insulin Resistance; Inflammation Biomarkers; Ketogenic Diet; Caloric Restriction; Obesity; Prediabetes; Metabolic Endotoxemia

• Registration Number: NCT06911879
• Lead Sponsor: University of Jordan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-05
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum Lipopolysaccharides (LPS) Levels	Baseline and after 12 weeks of intervention	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."

Secondary Outcome Measures

Name	Time	Method
TNF-α, IL-6 serum levels	Baseline and after 12 weeks of intervention	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.
Change in Fasting Glucose Level	Baseline and after 12 weeks of intervention	Fasting glucose will be measured to assess glycemic control before and after the dietary intervention.
Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)	Baseline and after 12 weeks of intervention	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.
Ketone bodies	week 6 and after 12 weeks of intervention	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."
Change in Body weight in kilograms	Baseline and every 2 weeks until week 12	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.
Dietary Intake using Food Records	week4, week 8 and week 12
Change in Fasting Insulin Level	Baseline and after 12 weeks of intervention	Fasting insulin will be measured to evaluate insulin levels at baseline and after 12 weeks of intervention
Change in HOMA-IR Index	Baseline and after 12 weeks of intervention	HOMA-IR index will be calculated using fasting insulin and glucose levels to evaluate changes in insulin resistance.
Height in meters	Baseline only	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.
Body fat percentage and lean body mass using bioelectrical impedance analysis (BIA)	Baseline and every 2 weeks until week 12	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.
Body Mass Index (BMI) in kg/m²	Baseline and every 2 weeks until week 12	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.

Trial Locations

Locations (1)

Aseel nutrition center; 🇯🇴 Amman, Jordan