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NCT Number: NCT06911918

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

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.

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Key information

Conditions

Insulin Resistance Behavior Body Weight Caloric Restriction Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Inflammation Biomarkers Intermittent Fasting Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity (Disorder) Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Time Restricted Eating

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Najd Nutri Center

Amman, 11110-17198, Jordan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Serum of TNF-α, IL-1β and IL-6

    Time frame: baseline and after 12 weeks of intervention

    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

Secondary outcomes

  1. Homa-IR

    Time frame: baseline and after 12 weeks of intervention

    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

  2. Lipid profile (LDL, HDL, TG, and cholesterol)

    Time frame: baseline and after 12 weeks of intervention

    will be analyzed at based line and post intervention to determine the impact of dietary modification on lipid profile

  3. body weight

    Time frame: baseline and every 2 weeks until 12 weeks of intervention

    in kilograms (Using inbody 120 )

  4. Dietary intake using food records

    Time frame: week4, week 8, and week 12 week

  5. Fasting blood glucose

    Time frame: baseline and after 12 weeks of intervention

  6. fasting insulin level

    Time frame: baseline and after 12 weeks of intervention

  7. height

    Time frame: baseline

    in centimeters, Height measuring scale - Stadiometer without shoes

  8. Body composition

    Time frame: baseline and every 2 weeks until 12 weeks of intervention

    %fat, fat in kilo grams, muscle mass in kilograms, using inbody 120

Study contacts

Contact information is provided by the study sponsor or research team.

Najd Abdullah Sarayreh, PhD

CONTACT

[email protected]

+962785556000 ext. 00962

Omar Mohammad Alkassasbeh, Master

CONTACT

[email protected]

00962785004201 ext. 00962

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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