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

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.

Conditions

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

Interventions

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

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

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

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

Sponsors & Collaborators

• University of Jordan

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-05

Primary Completion

2025-07-31

Completion

2025-11-30

Countries

• Jordan

Study Locations