Clinical trial NCT06911879: The Effect of Ketogenic-caloric Restricted Diet on Metabolic Endotoxemia in Prediabetic Obese Adults
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insulin Resistance
Metabolic Endotoxemia
Inflammation Biomarkers
Ketogenic Diet
Caloric Restriction
Obesity
Prediabetes
Keywords: ketogenic diet
Ketogenic-Caloric Restricted Diet
metabolic endotoxemia
insulin resistance
obesity
prediabetes
inflammation
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Serum Lipopolysaccharides (LPS) Levels
timeFrame: Baseline and after 12 weeks of intervention
Secondary outcomes:
measure: TNF-α, IL-6 serum levels
timeFrame: Baseline and after 12 weeks of intervention
measure: Change in Fasting Glucose Level
timeFrame: Baseline and after 12 weeks of intervention
measure: Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)
timeFrame: Baseline and after 12 weeks of intervention
measure: Ketone bodies
timeFrame: week 6 and after 12 weeks of intervention
measure: Change in Body weight in kilograms
timeFrame: Baseline and every 2 weeks until week 12
measure: Dietary Intake using Food Records
timeFrame: week4, week 8 and week 12
measure: Change in Fasting Insulin Level
timeFrame: Baseline and after 12 weeks of intervention
measure: Change in HOMA-IR Index
timeFrame: Baseline and after 12 weeks of intervention
measure: Height in meters
timeFrame: Baseline only
measure: Body fat percentage and lean body mass using bioelectrical impedance analysis (BIA)
timeFrame: Baseline and every 2 weeks until week 12
measure: Body Mass Index (BMI) in kg/m²
timeFrame: Baseline and every 2 weeks until week 12
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Aseel nutrition center
Study officials:
References: