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Comparing Intermittent Fasting and Mediterranean Diet for Obesity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07250659
Enrollment
120
Registered
2025-11-26
Start date
2022-09-01
Completion date
2022-12-30
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Keywords

obesity, intermittent fasting, weight loss, mediterranean diet

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.

Interventions

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.

OTHERMediterranean 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.

Sponsors

Kamil Dağcılar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Body weight (kg)Baseline and Week 4Body 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

MeasureTime frameDescription
Body Mass Index (kg/m²)Baseline and Week 4BMI is computed as weight in kilograms divided by height in meters squared (kg/m²)

Other

MeasureTime frameDescription
Fat Free Mass (kg)Baseline and Week 4Fat free mass is assessed using bioelectrical impedance analysis with TANITA BC-418
Total Body Water PercentageBaseline and Week 4Total body water percentage is assessed using bioelectrical impedance analysis with TANITA BC-418.
Body height (cm)Baseline onlyHeight 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.
Hip Circumference (cm)Baseline and Week 4Hip 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.
Waist Circumference (cm)Baseline and Week 4Waist 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.
Body Fat PercentageBaseline and week 4Body fat percentage is measured at baseline and Week 4 using the TANITA BC-418 body composition analyzer

Countries

Cyprus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026