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

NCT ID: NCT06911879

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-05
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketogenic diet with caloric restriction

Group Type: EXPERIMENTAL

Ketogenic diet with caloric restriction

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Normal diet with caloric restriction

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Normal diet without caloric restriction

Intervention Type: 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.

Interventions

Ketogenic diet with caloric restriction

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.

Intervention Type: OTHER

Normal diet with caloric restriction

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.

Intervention Type: OTHER

Normal diet without caloric restriction

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Aseel Basem jawamis

Principal Investigator, PhD Candidate in Human Nutrition and Dietetics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aseel nutrition center

Amman, , Jordan

Countries

Jordan

Central Contacts

Aseel Basem Jawamis, MSc, PhD Candidate

Role: CONTACT

aseelabujamous92@yahoo.com

+962795820919

Facility Contacts

Role: primary

aseelabujamous92@yahoo.com

+962795820919

Other Identifiers

381/2025

Identifier Type: -

Identifier Source: org_study_id