NCT06911879Completed
The Effect of Ketogenic-caloric Restricted Diet on Metabolic Endotoxemia in Prediabetic Obese Adults
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
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 20 Mar 2025
- Start date
- 5 May 2025
- Primary completion date
- 5 Aug 2025
- Lead sponsor
- University of Jordan
- Diseases
- Obesity
- NCT number
- NCT06911879
What you commit to
- Study type: Interventional
- Participants enrolled: 90
- From 5 May 2025 to the primary completion date, 5 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- • 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
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aseel nutrition center Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.