About this trial
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.
Eligibility criteria
Qualifiers
IR individuals diagnosed with IR by the physicians as indicated by HOMA-IR score
female and male, BMI ≥ 30 to 39.9 kg/m2
age between 18 and 40 years
stable weight for 3 months before the beginning of the study
Disqualifiers
previous weight loss surgery
pregnancy or intent to become pregnant
breastfeeding
chronic diseases
Trial design
Treatments tested in this trial
- time restricted eating with caloric restriction
- time restricted eating without caloric restriction
- Caloric restriction without Time restricted eating
- No time restricted eating - Normal diet