Clinical Trial

The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old

Not Yet Recruiting
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Record status
This record was last updated April 4, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
Summary
Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and pro-inflammatory biomarkers among prediabetic obese Jordanian adults aged 18-40 years. The study assesses changes in pro-inflammatory biomarkers (IL-1β, TNF-α, IL-6), insulin resistance (HOMA-IR), and body composition over 12 weeks. Participants (n=120) will be randomized into four intervention arms: (1) TRE with CR, (2) TRE without CR, (3) CR without TRE, and (4) a control group with no dietary restrictions and no TRE. Biweekly anthropometric assessments will evaluate pro-inflammatory biomarkers and biochemical measures at baseline and the end of the study. The findings will provide insights into the comparative effectiveness of TRE and CR, potentially offering a safe, cost-effective intervention to prevent obesity-induced inflammation, prediabetes, and progression to type 2 diabetes mellitus.
Trial Details
NCT Number NCT06911918
Lead Sponsor University of Jordan
Conditions Insulin Resistance, Inflammation Biomarkers, Time Restricted Eating, Caloric Restriction, Obesity (Disorder)
Enrollment 120 participants
Start Date 2025-04-05
Primary Completion 2025-07 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2025-04-04