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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06911918
• Lead Sponsor: University of Jordan

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-05
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Serum of TNF-α, IL-1β and IL-6	baseline and after 12 weeks of intervention	Will be measured using ELISA before and after dietary intervention to assess the impact of time restricted eating on these proinflammatory biomarkers in participants diagnosed with Insulin resistance

Secondary Outcome Measures

Name	Time	Method
Homa-IR	baseline and after 12 weeks of intervention	Homa-IR will be assessed using the homeostasis model assessment (HOMA) method, which involves applying the formula \[fasting glucose (mg/dL) \* fasting insulin (mU/mL)/ 405\] to evaluate the changes in insulin resistance over 12 weeks of intervention
Lipid profile (LDL, HDL, TG, and cholesterol)	baseline and after 12 weeks of intervention	will be analyzed at based line and post intervention to determine the impact of dietary modification on lipid profile
body weight	baseline and every 2 weeks until 12 weeks of intervention	in kilograms (Using inbody 120 )
Dietary intake using food records	week4, week 8, and week 12 week
Fasting blood glucose	baseline and after 12 weeks of intervention
fasting insulin level	baseline and after 12 weeks of intervention
height	baseline	in centimeters, Height measuring scale - Stadiometer without shoes
Body composition	baseline and every 2 weeks until 12 weeks of intervention	%fat, fat in kilo grams, muscle mass in kilograms, using inbody 120

Trial Locations

Locations (1)

Najd Nutri Center; 🇯🇴 Amman, Jordan