Status:
NOT_YET_RECRUITING
The Effect of Ketogenic-caloric Restricted Diet on Metabolic Endotoxemia in Prediabetic Obese Adults
Lead Sponsor:
University of Jordan
Conditions:
Insulin Resistance
Metabolic Endotoxemia
Eligibility:
All Genders
18-40 years
Phase:
NA
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 lipopo...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
April 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06911879
Start Date
April 5 2025
End Date
November 1 2025
Last Update
April 4 2025
Active Locations (1)
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1
Aseel nutrition center
Amman, Jordan