Comparative Effects of Intermittent Fasting Versus Mediterranean Diet on Obesity Management: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Body weight (kg)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
intermittent fasting diet intervention group
4 week time restricted intermittent fasting diet protocol
Intervention: Intermittent Fasting Diet (Other)
Mediterranean diet intervention group
4 week mediterranean diet protocol
Intervention: Mediterranean Diet (Other)
Outcomes
Primary Outcomes
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
- Body Mass Index (kg/m²)(Baseline and Week 4)
Investigators
Kamil Dağcılar
Assistant Professor
European University of Lefke