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

April 28, 2026 updated by: Aseel Basem jawamis, University of Jordan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan
        • Aseel nutrition center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketogenic diet with caloric restriction
Other: 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.
Active Comparator: Normal diet with caloric restriction
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.
Active Comparator: Normal diet without caloric restriction
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
Baseline and after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 12 weeks of intervention
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.
Baseline and after 12 weeks of intervention
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.
Baseline and after 12 weeks of intervention
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."
week 6 and after 12 weeks of intervention
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.
Baseline and every 2 weeks until week 12
Dietary Intake using Food Records
Time Frame: week4, week 8 and week 12
week4, week 8 and week 12
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
Baseline and after 12 weeks of intervention
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.
Baseline and after 12 weeks of intervention
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.
Baseline only
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.
Baseline and every 2 weeks until week 12
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.
Baseline and every 2 weeks until week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2025

Primary Completion (Actual)

August 5, 2025

Study Completion (Actual)

August 5, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 381/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) will not be shared due to privacy concerns and institutional policies. Data access is restricted to the research team to ensure confidentiality and compliance with ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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