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

University of Jordan

Status: Not yet enrolling

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

Treatments: Other: Ketogenic diet with caloric restriction; Other: Normal diet with caloric restriction; Other: Normal diet without caloric restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT06911879

381/2025

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Ketogenic diet with caloric restriction

Experimental group

Treatment:

Other: Ketogenic diet with caloric restriction

Normal diet with caloric restriction

Active Comparator group

Treatment:

Other: Normal diet with caloric restriction

Normal diet without caloric restriction

Active Comparator group

Treatment:

Other: Normal diet without caloric restriction