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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Jordan

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

Treatment groups

120 Participants
are divided into 4 treatment groups

Sponsors and collaborators