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

NCT06911918 | Not Yet Recruiting

• 1 other identifier: 382/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Time restricted eating; Insulin Resistance; Obesity; Caloric Restriction; Inflammation cytokines

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and after 12 weeks of intervention

Secondary Outcomes (8)

• Homa-IR

  baseline and after 12 weeks of intervention

• Lipid profile (LDL, HDL, TG, and cholesterol)

  baseline and after 12 weeks of intervention

• body weight

  baseline and every 2 weeks until 12 weeks of intervention

• Dietary intake using food records

  week4, week 8, and week 12 week

• Fasting blood glucose

  baseline and after 12 weeks of intervention

Study Arms (4)

10-h Time restricted eating with caloric restriction

EXPERIMENTAL

Other: time restricted eating with caloric restriction

10-h time restricted eating without caloric restriction

ACTIVE COMPARATOR

Other: time restricted eating without caloric restriction

caloric restriction without time restricted eating

ACTIVE COMPARATOR

Other: Caloric restriction without Time restricted eating

No time restricted eating - normal diet

ACTIVE COMPARATOR

Other: No time restricted eating - Normal diet

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

10-h Time restricted eating with caloric restriction

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

10-h time restricted eating without caloric restriction

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

caloric restriction without time restricted eating

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

No time restricted eating - normal diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Najd Nutri Center

Amman, 11110-17198, Jordan

Location

MeSH Terms

Conditions

Insulin Resistance; Intermittent Fasting; Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fasting; Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Najd Abdullah Sarayreh, PhD

CONTACT

+962785556000; najd.nutricenter@gmail.com

Omar Mohammad Alkassasbeh, Master

CONTACT

00962785004201; kasasbeh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, PhD Candidate in Human Nutrition and Dietetics

Model Details: This open-label, 12-week randomized controlled experimental trial factorial 2X2 with a 1:1 allocation ratio

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: April 5, 2025
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)