Comparing Intermittent Fasting and Mediterranean Diet for Obesity

NCT07250659 | Completed DMC

• 1 other identifier: BAYEK011.02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weight Loss

Keywords

obesity; intermittent fasting; weight loss; mediterranean diet

Outcome Measures

Primary Outcomes (1)

• Body weight (kg)

  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.

  Baseline and Week 4

Secondary Outcomes (1)

• Body Mass Index (kg/m²)

  Baseline and Week 4

Other Outcomes (6)

• Body height (cm)

  Baseline only

• Body Fat Percentage

  Baseline and week 4

• Fat Free Mass (kg)

  Baseline and Week 4

Study Arms (2)

intermittent fasting diet intervention group

EXPERIMENTAL

4 week time restricted intermittent fasting diet protocol

Other: Intermittent Fasting Diet

Mediterranean diet intervention group

EXPERIMENTAL

4 week mediterranean diet protocol

Other: Mediterranean Diet

Interventions

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.

intermittent fasting diet intervention group

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.

Mediterranean diet intervention group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kamil Dağcılar: lead

Study Sites (1)

European University of Lefke

Lefka, 99770, Cyprus

Location

MeSH Terms

Conditions

Weight Loss; Obesity; Intermittent Fasting

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: September 1, 2022
• Primary Completion: December 25, 2022
• Study Completion: December 30, 2022
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CY (1)