NCT07378267

Brief Summary

Cardiovascular diseases (CVD), cancer, diabetes, stroke, and chronic lung diseases are non-communicable diseases (NCDs) and account for a significant portion of deaths worldwide. In Turkey, it is estimated that 90% of all deaths are due to NCDs, with 34% due to CVD, 23% due to cancer, 7% due to chronic lung disease, and 5% due to diabetes. Inadequate and unbalanced nutrition and lack of physical activity contribute to the development of non-communicable diseases. Risk factors such as hypertension, hypercholesterolemia, and obesity are effective in increasing NCDs. In Turkey, it has been found that 32% of NCD-related deaths in individuals over 18 years of age and 10% in adolescents aged 10-19 years are due to obesity risk factors. All overweight and obese adults with a Body Mass Index (BMI) ≥25 are at risk of developing hypertension, hypercholesterolemia, type 2 diabetes, and CVD. Preventing obesity is effective in preventing these diseases. Weight loss is important in the treatment and prevention of obesity. Changes in body weight are focused on changes in diet and physical activity. Creating an energy deficit is necessary to achieve weight loss, and there are different dietary approaches to reduce energy intake. The Mediterranean diet model and the Intermittent Fasting model are important and being researched in this context.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 17, 2026

Last Update Submit

January 26, 2026

Conditions

Obesity & Overweight

Keywords

intermittent fastingMediterranean diet

Outcome Measures

Primary Outcomes (2)

  • Adult Nutrition Knowledge Level (ADHL) Scale

    The survey form containing Basic Nutrition and Food-Health Information will be completed. Participants who marked "Strongly Agree" for correct statements received 4 points, those who marked "Agree" received 3 points, those who marked "Neither Agree nor Disagree" received 2 points, those who chose "Disagree" received 1 point, and those who chose "Strongly Disagree" received 0 points. Items 1, 3, 6, 8, 13, 16, 19, and 20 of the scale are reverse scored. The highest possible score for the basic nutrition section is 80; the highest possible score for the food preference section is 48. A basic nutrition score of \<45 is considered poor, 45-55 is considered average, 56-65 is considered good, and 65 and above is considered very good. In terms of food preference scores, a score of \<30 is considered poor, 30-36 points are considered average, 37-42 points are considered good, and 42 points and above are considered very good.

    8 weeks

  • Body fat percentage (%Fat)

    Individuals' body weights and body compositions will be measured using foot-to-foot bioelectrical impedance analysis (BIA). Body fat percentage (%Fat) will be measured using TANITA MC 580.

    8 weeks

Secondary Outcomes (3)

  • Body fat mass (kg)

    8 weeks

  • Weight

    8 weeks

  • Body mass index (BMI)

    8 weeks

Study Arms (2)

Mediterranean diet group

ACTIVE COMPARATOR

Mediterranean diet

Other: Mediterranean diet

intermittent fasting group

ACTIVE COMPARATOR

intermittent fasting

Other: intermittent fasting

Interventions

Mediterranean dietOTHER

The participants in the study were divided into two different diet groups: Mediterranean diet (MD) and intermittent fasting (IF). The "Harris Benedict" formula was used to calculate the Basal Metabolic Rate (BMR) of the individuals. For men, the BMR was calculated as 66.5 + (13.7516 × weight in kg) + (5.0033 × height in cm) - (6.755 × age in years); for women, the BMR was calculated as 655.1 + (9.5634 × weight in kg) + (1.8496 × height in cm) - (4.6756 × age in years). Physical activity level (PAL) was determined as follows: sedentary physical activity level 1-1.39; light physical activity level 1.4-1.59; moderate physical activity level 1.6-1.89; and heavy physical activity level 1.9-2.5. Total energy expenditure (TED) was calculated using the formula: TED (kcal/day) = BMR (kcal/day) x PAL (Ministry of Health, 2017). For the group following the Mediterranean diet, diet plans were prepared containing 35-40% carbohydrates, 15-20% protein, and 35-45% fat of daily energy. A nutritional pr

Mediterranean diet group
intermittent fastingOTHER

The participants in the study were divided into two different diet groups: Mediterranean diet (MD) and intermittent fasting (IF). The "Harris Benedict" formula was used to calculate the Basal Metabolic Rate (BMR) of the individuals. For men, the BMR was calculated as 66.5 + (13.7516 × weight in kg) + (5.0033 × height in cm) - (6.755 × age in years); for women, the BMR was calculated as 655.1 + (9.5634 × weight in kg) + (1.8496 × height in cm) - (4.6756 × age in years). Physical activity level (PAL) was determined as follows: sedentary physical activity level 1-1.39; light physical activity level 1.4-1.59; moderate physical activity level 1.6-1.89; and heavy physical activity level 1.9-2.5. Total energy expenditure (TED) was calculated using the formula: TED (kcal/day) = BMR (kcal/day) x PAL (Ministry of Health, 2017). Individuals in the intermittent fasting group also had time restrictions applied in addition to the Mediterranean diet group. Time preferences were determined as 16/8, 14

intermittent fasting group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 18-65 years old
  • Having a BMI value between 27 kg/m2 - 35 kg/m2
  • HBA1C levels between 3.9-6.1
  • HOMA IR \<2.5
  • Not having any conditions that impair reality testing and cognitive functions, preventing interviewing or completing scales
  • Being literate
  • Having signed the informed consent form by agreeing to participate in the research

You may not qualify if:

  • Being pregnant or breastfeeding,
  • Liver and kidney disease,
  • Use of insulin and oral antidiabetic drugs,
  • Defined as a psychiatric illness diagnosed by a physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eda Ocak Nutrition and Diet Consultancy

Konya, Selçuklu, 42100, Turkey (Türkiye)

Location

Related Publications (1)

  • Antoni, R., Robertson, T. M., Robertson, M. D., Johnston, J. (2018). A pilot feasibility study exploring the effects of a moderate time-restricted feeding intervention on energy intake, adiposity and metabolic physiology in free-living human subjects. 7. doi:https://doi.org/10.1017/jns.2018.13

    RESULT

MeSH Terms

Conditions

ObesityOverweightIntermittent Fasting

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ebru Bayrak, assistant professor

    Selcuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study was planned as a randomized trial using a dietary intervention method (Mediterranean Diet intervention group and Intermittent Fasting Diet group). First, inclusion criteria for randomization were determined, and 100 participants meeting these criteria who applied to a private diet clinic after a health screening from a family physician in Selçuklu district of Konya province will be assigned numbers. Individuals will be placed in the group corresponding to the dietary intervention group with the number they received in randomization. Dietary intervention will be applied to both groups in the study. After obtaining informed consent from the participants, an 8-week follow-up period will begin.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dietician

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 30, 2026

Study Start

February 18, 2023

Primary Completion

May 18, 2023

Study Completion

October 30, 2023

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

only IPD used in the results publication.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
February 2023 - November 2023
Access Criteria
Access criteria will be shared with researchers who meet the following conditions: Being employed by a recognized academic institution, university, research hospital, or public research organization; Providing documentation that the study in which the requested data will be used has scientific, ethical, and social benefit purposes; Submitting a research protocol approved by the relevant institution or ethics committee; Committing that the data will be used only for secondary analysis or meta-analysis.

Locations

TU(1)