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Completed

NCT Number: NCT07250659

Comparing Intermittent Fasting and Mediterranean Diet for Obesity

Purpose: This study aimed to evaluate and compare the effects of intermittent fasting (IF) and the Mediterranean diet (MD) on weight loss in obese adults.

Methods: A total of 120 adults diagnosed with obesity were enrolled. Baseline data on physical activity and dietary intake were collected through structured interviews. Participants were randomly assigned to two groups for a 4-week intervention. The IF group followed a time-restricted eating schedule (16:8), while the MD group followed a structured plan of three main meals and three snacks daily. Both diets included a 500-calorie daily reduction from estimated energy needs. Anthropometric measurements were recorded at baseline and week 4.

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Key information

Conditions

Weight Loss Behavior Body Weight Body Weight Changes Fasting Feeding Behavior Intermittent Fasting Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European University of Lefke

Lefka, 99770, Cyprus

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI ≥ 30 kg/m²
  • absence of chronic diseases
  • no regular use of medications
  • non smokers
  • non alcohol users
  • not pregnant or breastfeeding
  • no history of bariatric surgery
  • no significant weight fluctuations (±5 kg) in the past 6 months
  • no pregnancy plans during the study period

Exclusion criteria

  • BMI < 30 kg/m²
  • Presence of any diagnosed chronic disease (e.g., diabetes, cardiovascular disease, thyroid disorders, renal or hepatic disease)
  • Regular use of medications that could affect metabolism, appetite, or body weight
  • Smoking or alcohol consumption
  • Pregnancy or breastfeeding during the study period
  • History of bariatric or other weight-related surgical procedures
  • Significant weight changes (gain or loss ≥5 kg) within the past 6 months
  • Planning pregnancy during the study period
  • Inability or unwillingness to comply with dietary intervention and follow-up requirements

Treatment and study plan

Intermittent Fasting Diet

Other

Participants follow a time-restricted eating pattern for 4 weeks, consuming all meals within an 8-hour eating window (from 1:00 PM to 9:00 PM) and fasting for the remaining 16 hours each day. During the feeding window, they consume two main meals and one snack based on ad libitum intake, without specific calorie restriction. Dietary guidance is provided at the start and mid-point of the protocol by a registered dietitian.

Mediterranean Diet

Other

Participants follow a 4-week Mediterranean diet protocol that is adapted from the PREDIMED criteria and the MedDietScore index. The diet emphasizes high consumption of vegetables, fruits, legumes, whole grains, nuts, and olive oil; moderate intake of fish and poultry; and limited consumption of red meat, dairy products, and sweets. A registered dietitian provides dietary counseling sessions at the beginning and midway through the intervention.

Primary outcomes

  1. Body weight (kg)

    Time frame: Baseline and Week 4

    Body weight is measured with using the TANITA BC-418 body composition analyzer. Participants are weighed barefoot, in light clothing, and measurements are recorded in kilograms.

Secondary outcomes

  1. Body Mass Index (kg/m²)

    Time frame: Baseline and Week 4

    BMI is computed as weight in kilograms divided by height in meters squared (kg/m²)

Other outcomes

  1. Body height (cm)

    Time frame: Baseline only

    Height is measured once at baseline using a wall-mounted stadiometer. Participants stand barefoot, with heels together, arms at the sides, and head positioned in the Frankfurt horizontal plane. The measurement is recorded to the nearest 0.1 centimeter and converted to meters.

  2. Body Fat Percentage

    Time frame: Baseline and week 4

    Body fat percentage is measured at baseline and Week 4 using the TANITA BC-418 body composition analyzer

  3. Fat Free Mass (kg)

    Time frame: Baseline and Week 4

    Fat free mass is assessed using bioelectrical impedance analysis with TANITA BC-418

  4. Total Body Water Percentage

    Time frame: Baseline and Week 4

    Total body water percentage is assessed using bioelectrical impedance analysis with TANITA BC-418.

  5. Waist Circumference (cm)

    Time frame: Baseline and Week 4

    Waist circumference is measured using a non-elastic, flexible measuring tape. The measurement is taken at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest, while the participant stands upright with feet close together and breathes out normally.

  6. Hip Circumference (cm)

    Time frame: Baseline and Week 4

    Hip circumference is measured with using a non-elastic measuring tape. The measurement is taken around the widest portion of the buttocks, with the participant standing upright and feet together.

Sponsors and collaborators

Lead sponsor

Kamil Dağcılar

Other

Registry information

Official study title

Comparative Effects of Intermittent Fasting Versus Mediterranean Diet on Obesity Management: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2025
Registry last updated
Nov 26, 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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