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

Sponsor
University of Jordan
Study ID
NCT06911918
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • time restricted eating with caloric restriction — OTHER
    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
  • time restricted eating without caloric restriction — OTHER
    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
  • Caloric restriction without Time restricted eating — OTHER
    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
  • No time restricted eating - Normal diet — OTHER
    will be asked to maintain their normal diet as the second intervention arm without time restricted eating throughout the trial

Study Details

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.

Key Dates

First listed
Apr 4, 2025
Start date
Apr 5, 2025
Status verified
Mar 2025
Primary completion
Jul 31, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: 10-h Time restricted eating with caloric restriction
  • Active Comparator: 10-h time restricted eating without caloric restriction
  • Active Comparator: caloric restriction without time restricted eating
  • Active Comparator: No time restricted eating - normal diet

Primary Outcome Measure

Serum of TNF-α, IL-1β and IL-6 [ Time Frame: baseline and after 12 weeks of intervention ]

Central Contacts

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