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Trial registered on ANZCTR


Registration number
ACTRN12625000207415
Ethics application status
Approved
Date submitted
9/01/2025
Date registered
21/02/2025
Date last updated
21/02/2025
Date data sharing statement initially provided
21/02/2025
Date results information initially provided
21/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Energy-Restricted Mediterranean Diet on Telomere Length in overweight and obese Individuals
Scientific title
The Impact of an Energy-Restricted Mediterranean Diet on Telomere Length in Overweight and Obese Individuals
Secondary ID [1] 313662 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 336232 0
overweight 336235 0
Condition category
Condition code
Diet and Nutrition 332770 332770 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Energy Restricted Mediterranean Diet is given to patients by dietician. They will be asked to consume Energy-restricted Mediterranean diet with 50-60% carbohydrates, 15-20% protein, and 25-30% fat. Diet lists were prepared by the dietician for the individuals participating in the study to consume Mediterranean diet for 8 weeks. According to personal preferences, daily planning was made as "3 main meals and 3 snacks" or "3 main meals and 2 snacks".
Participants received training on the Mediterranean diet pyramid and recommendations for weekly and daily food group consumption. Diets were organized to ensure a Mediterranean diet score of at least 11 according to "Stefler D, Malyutina S, Kubinova R, Pajak A, Peasey A, Pikhart H, et al. Mediterranean diet score and total and cardiovascular mortality in Eastern Europe: the HAPIEE study. Eur J Nutr. 2017;56(1):421–9. ". The duration of the intervention is 8 weeks. The administration of the diet is done by dietician by face to face consultation.
To assess the dietary adherence and body weight loss of the overweight and obese group, the researcher conducted biweekly interviews, monitored their body weight and composition, and engaged in weekly phone calls to evaluate their compliance with the diet and provide motivation. The dietitian assessed the individuals face-to-face with approximately half-hour interviews once every 15 days for 8 weeks. Telephone calls for evaluation and motivational purposes are approximately 15 minutes per week.
Intervention code [1] 330261 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340295 0
Telomere Length
Timepoint [1] 340295 0
Baseline and 8th week after the intervention begin
Secondary outcome [1] 443642 0
Body composition (total fat percentage, lean muscle percentage, body water) is analyzed by BIA method total fat percentage, lean muscle percentage, body water
Timepoint [1] 443642 0
Baseline, every 2 weeks up to the 8th week post-intervention commencement
Secondary outcome [2] 443643 0
HDL-Cholesterol (HDL-C)
Timepoint [2] 443643 0
Baseline and 8th week post-intervention commencement
Secondary outcome [3] 444190 0
LDL-Cholesterol (LDL-C) and Total Cholesterol (Total-C)
Timepoint [3] 444190 0
Baseline and 8th week post-intervention commencement
Secondary outcome [4] 444191 0
Glucose
Timepoint [4] 444191 0
Baseline and 8th week post-intervention commencement
Secondary outcome [5] 444194 0
C-reactive protein
Timepoint [5] 444194 0
Baseline and 8th week post-intervention commencement
Secondary outcome [6] 444195 0
TNF- a
Timepoint [6] 444195 0
Baseline and 8th week post-intervention commencement
Secondary outcome [7] 444196 0
IL-6 levels
Timepoint [7] 444196 0
Baseline and 8th week post-intervention commencement
Secondary outcome [8] 444197 0
Total antioxidant status (TAS) and Total oxidant status (TOS)
Timepoint [8] 444197 0
Baseline and 8th week post-intervention commencement

Eligibility
Key inclusion criteria
Female participants between aged 20-50, with a BMI between 25-29.9 kg/m2(overweight group) (n=14), greater than 30 kg/m2(obese group) (n=14), and who applied to the Nutrition and Dietetics Clinic of Gazi University, Faculty of Health Sciences, Department of Nutrition and Dietetics, were included in the study.
Minimum age
20 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
smoking, chronic diseases except for hyperlipidemia and hypertension, males, pregnant females, breastfeeding females, heavy exercisers, vitamin-mineral supplements or nutritional supplement users, and having another special diet.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/02/2021
Date of last participant enrolment
Anticipated
Actual
23/02/2022
Date of last data collection
Anticipated
Actual
23/05/2022
Sample size
Target
28
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 26808 0
Turkey
State/province [1] 26808 0

Funding & Sponsors
Funding source category [1] 318127 0
University
Name [1] 318127 0
Gazi University
Country [1] 318127 0
Turkey
Primary sponsor type
University
Name
Gazi University Scientific Research Projects Unit (BAP)
Address
Country
Turkey
Secondary sponsor category [1] 320511 0
None
Name [1] 320511 0
Address [1] 320511 0
Country [1] 320511 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316775 0
Gazi University Clinical Trials Ethics Committee
Ethics committee address [1] 316775 0
Gazi University, Medicine Faculty, 06500 Besevler/ANKARA/TÜRKIYE
Ethics committee country [1] 316775 0
Turkey
Date submitted for ethics approval [1] 316775 0
15/04/2020
Approval date [1] 316775 0
18/06/2020
Ethics approval number [1] 316775 0
416

Summary
Brief summary
This study investigates the effects of an energy-restricted Mediterranean diet on telomeres in overweight and obese individuals. It includes female participants aged 20-50 at Gazi University, Türkiye, over an eight-week period. Data on demographics, dietary records, body composition, anthropometric measurements, and physical activity levels are collected. The Mediterranean Adequacy Index (MAI) is calculated at the beginning and end of the study. Participants follow an individualized energy-restricted Mediterranean diet. Biochemical parameters such as glucose, HDL-C, LDL-C, Total-C, C-reactive protein, TNF-a, IL-6, TAS, TOS, and telomere length are analyzed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138974 0
Dr Neslihan ARSLAN
Address 138974 0
Health Sciences University, Gülhane Health Sciences Faculty, Nutrition and Dietetics Department, Emrah district 06018 Keçiören ANKARA
Country 138974 0
Turkey
Phone 138974 0
+9005331625286
Fax 138974 0
Email 138974 0
[email protected]
Contact person for public queries
Name 138975 0
Ilke Hacer ONEN
Address 138975 0
Gazi University Faculty of Medicine Emniyet District, Mevlana Bulvari No: 29 06500 Yenimahalle/Ankara/Türkiye
Country 138975 0
Turkey
Phone 138975 0
+905426870626
Fax 138975 0
Email 138975 0
[email protected]
Contact person for scientific queries
Name 138976 0
Eda KÖKSAL
Address 138976 0
University of Gazi, Faculty of Health Sciences, Department of Nutrition and Dietetics Emek District. Biskek Street. 6th Street (former 81st street) No:2 06490 Çankaya/ANKARA
Country 138976 0
Turkey
Phone 138976 0
+9005442697939
Fax 138976 0
Email 138976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.