Clinical trial NCT06911918: The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insulin Resistance
Inflammation Biomarkers
Time Restricted Eating
Caloric Restriction
Obesity (Disorder)
Keywords: Time restricted eating
Insulin Resistance
Obesity
Caloric Restriction
Inflammation cytokines
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This open-label, 12-week randomized controlled experimental trial factorial 2X2 with a 1:1 allocation ratio
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Serum of TNF-α, IL-1β and IL-6
timeFrame: baseline and after 12 weeks of intervention
Secondary outcomes:
measure: Homa-IR
timeFrame: baseline and after 12 weeks of intervention
measure: Lipid profile (LDL, HDL, TG, and cholesterol)
timeFrame: baseline and after 12 weeks of intervention
measure: body weight
timeFrame: baseline and every 2 weeks until 12 weeks of intervention
measure: Dietary intake using food records
timeFrame: week4, week 8, and week 12 week
measure: Fasting blood glucose
timeFrame: baseline and after 12 weeks of intervention
measure: fasting insulin level
timeFrame: baseline and after 12 weeks of intervention
measure: height
timeFrame: baseline
measure: Body composition
timeFrame: baseline and every 2 weeks until 12 weeks of intervention
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Najd Nutri Center
Study officials:
References: