The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: time restricted eating with caloric restriction, time restricted eating without caloric restriction, Caloric restriction without Time restricted eating, No time restricted eating - Normal diet.
- Who it may be relevant to
- Registry conditions: Insulin Resistance, Inflammation Biomarkers, Time Restricted Eating, Caloric Restriction. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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
Primary outcome measures
- Serum of TNF-α, IL-1β and IL-6 [Time frame: baseline and after 12 weeks of intervention]
Secondary outcome measures (8)
- Homa-IR [Time frame: baseline and after 12 weeks of intervention]
- Lipid profile (LDL, HDL, TG, and cholesterol) [Time frame: baseline and after 12 weeks of intervention]
- body weight [Time frame: baseline and every 2 weeks until 12 weeks of intervention]
- Dietary intake using food records [Time frame: week4, week 8, and week 12 week]
- Fasting blood glucose [Time frame: baseline and after 12 weeks of intervention]
- fasting insulin level [Time frame: baseline and after 12 weeks of intervention]
- height [Time frame: baseline]
- Body composition [Time frame: baseline and every 2 weeks until 12 weeks of intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Jordan · 1 center
- Najd Nutri Center — Amman
Identifiers
NCT: NCT06911918 · 382/2025