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NCT Number: NCT06911879

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.

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Key information

Conditions

Insulin Resistance Body Weight Caloric Restriction Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Inflammation Inflammation Biomarkers Ketogenic Diet Metabolic Diseases Metabolic Endotoxemia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aseel nutrition center

Amman, Jordan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Serum Lipopolysaccharides (LPS) Levels

    Time frame: 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 outcomes

  1. TNF-α, IL-6 serum levels

    Time frame: 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.

  2. Change in Fasting Glucose Level

    Time frame: Baseline and after 12 weeks of intervention

    Fasting glucose will be measured to assess glycemic control before and after the dietary intervention.

  3. Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)

    Time frame: 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.

  4. Ketone bodies

    Time frame: 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."

  5. Change in Body weight in kilograms

    Time frame: 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.

  6. Dietary Intake using Food Records

    Time frame: week4, week 8 and week 12

  7. Change in Fasting Insulin Level

    Time frame: Baseline and after 12 weeks of intervention

    Fasting insulin will be measured to evaluate insulin levels at baseline and after 12 weeks of intervention

  8. Change in HOMA-IR Index

    Time frame: 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.

  9. Height in meters

    Time frame: 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.

  10. Body fat percentage and lean body mass using bioelectrical impedance analysis (BIA)

    Time frame: 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.

  11. Body Mass Index (BMI) in kg/m²

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

The Effect of Ketogenic-Caloric Restricted Dietary Intervention on Metabolic Endotoxemia Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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