Comparing Intermittent Fasting and Mediterranean Diet for Obesity

NCT ID: NCT07250659

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2022-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intermittent fasting diet intervention group

4 week time restricted intermittent fasting diet protocol

Group Type: EXPERIMENTAL

Intermittent Fasting Diet

Intervention Type: 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 intervention group

4 week mediterranean diet protocol

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: 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.

Interventions

Intermittent Fasting Diet

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.

Intervention Type: OTHER

Mediterranean Diet

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kamil Dağcılar

OTHER

Sponsor Role: lead

Responsible Party

Kamil Dağcılar

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

European University of Lefke

Lefka, , Cyprus

Countries

Cyprus

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

BAYEK011.02

Identifier Type: -

Identifier Source: org_study_id