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

University of Jordan

Status: Not yet enrolling

Conditions: Inflammation Biomarkers; Time Restricted Eating; Caloric Restriction; Insulin Resistance; Obesity (Disorder)

Treatments: Other: time restricted eating with caloric restriction; Other: time restricted eating without caloric restriction; Other: No time restricted eating - Normal diet; Other: Caloric restriction without Time restricted eating

Study type: Interventional

Funder types: Other

Identifiers

NCT06911918

382/2025

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• sedentary lifestyle

Exclusion criteria

• previous weight loss surgery
• pregnancy or intent to become pregnant
• breastfeeding
• chronic diseases
• drug therapies that could interfere with the effectiveness of the dietary intervention (e.g., use of corticosteroids, and anti-diabetic drugs)
• diabetic type 1 and 2 individuals
• anyone physically active to reduce the influence of confounding covariates

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

10-h Time restricted eating with caloric restriction

Experimental group

Treatment:

Other: time restricted eating with caloric restriction

10-h time restricted eating without caloric restriction

Active Comparator group

Treatment:

Other: time restricted eating without caloric restriction

caloric restriction without time restricted eating

Active Comparator group

Treatment:

Other: Caloric restriction without Time restricted eating

No time restricted eating - normal diet

Active Comparator group

Treatment:

Other: No time restricted eating - Normal diet