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

NCT06911879 | Completed

• 1 other identifier: 381/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• TNF-α, IL-6 serum levels

  Baseline and after 12 weeks of intervention

• Change in Fasting Glucose Level

  Baseline and after 12 weeks of intervention

• Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)

  Baseline and after 12 weeks of intervention

• Ketone bodies

  week 6 and after 12 weeks of intervention

• Change in Body weight in kilograms

  Baseline and every 2 weeks until week 12

Study Arms (3)

Ketogenic diet with caloric restriction

EXPERIMENTAL

Other: Ketogenic diet with caloric restriction

Normal diet with caloric restriction

ACTIVE COMPARATOR

Other: Normal diet with caloric restriction

Normal diet without caloric restriction

ACTIVE COMPARATOR

Other: Normal diet without caloric restriction

Interventions

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.

Ketogenic diet with caloric restriction

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 with caloric restriction

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.

Normal diet without caloric restriction

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Aseel nutrition center

Amman, Jordan

Location

Related Publications (1)

• 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.

  PMID: 41747400 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Obesity; Prediabetic State; Inflammation

Interventions

Diet, Ketogenic; Caloric Restriction

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Energy Intake

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Candidate in Human Nutrition and Dietetics

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: May 5, 2025
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: May 5, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)