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.
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
previous weight loss surgery
pregnancy or intent to become pregnant
breastfeeding
chronic diseases
Factorial
time restricted eating with caloric restriction
Other interventionwill 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 interventionwill 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 interventionwill 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 interventionwill be asked to maintain their normal diet as the second intervention arm without time restricted eating throughout the trial
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
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
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
body weight
in kilograms (Using inbody 120 )
Dietary intake using food records
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