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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insulin Resistance; Time Restricted Eating; Obesity (Disorder); Caloric Restriction; Inflammation Biomarkers
• Intervention / Treatment: Other: time restricted eating with caloric restriction; Other: time restricted eating without caloric restriction; Other: Caloric restriction without Time restricted eating; Other: No time restricted eating - Normal diet

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Najd Abdullah Sarayreh, PhD; Phone Number: 00962 +962785556000; Email: najd.nutricenter@gmail.com
• Study Contact Backup: Name: Omar Mohammad Alkassasbeh, Master; Phone Number: 00962 00962785004201; Email: kasasbeh@gmail.com

Study Locations

• Jordan
  • Amman, Jordan, 11110-17198
    • Najd Nutri Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10-h Time restricted eating with caloric restriction	Other: time restricted eating with caloric restriction; will be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value and fasted from 18:00 to 8:00 daily (a 14-h fast) in the 12-weeks intervention
Active Comparator: 10-h time restricted eating without caloric restriction	Other: time restricted eating without caloric restriction; will be asked to maintain their normal diet to the acceptable normal distribution ranges and fast from 8:00 to 18:00. They do not need to restrict caloric intake during the feeding window
Active Comparator: caloric restriction without time restricted eating	Other: Caloric restriction without Time restricted eating; will be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value
Active Comparator: No time restricted eating - normal diet	Other: No time restricted eating - Normal diet; will be asked to maintain their normal diet as the second intervention arm without time restricted eating throughout the trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum of TNF-α, IL-1β and IL-6	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	baseline and after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homa-IR	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	baseline and after 12 weeks of intervention
Lipid profile (LDL, HDL, TG, and cholesterol)	will be analyzed at based line and post intervention to determine the impact of dietary modification on lipid profile	baseline and after 12 weeks of intervention
body weight	in kilograms (Using inbody 120 )	baseline and every 2 weeks until 12 weeks of intervention
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	in centimeters, Height measuring scale - Stadiometer without shoes	baseline
Body composition	%fat, fat in kilo grams, muscle mass in kilograms, using inbody 120	baseline and every 2 weeks until 12 weeks of intervention

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Insulin Resistance; Caloric Restriction; Time restricted eating; Inflammation cytokines
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Hyperinsulinism; Overweight; Obesity; Inflammation; Insulin Resistance
• Other Study ID Numbers: 382/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data IPD will not be shared due to privacy concerns and institutional polices. Data access is restricted to the research team to ensure confidentially and compliance with ethical guidelines

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No