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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 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
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Scientific title
The Impact of an Energy-Restricted Mediterranean Diet on Telomere Length in Overweight and Obese Individuals
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Secondary ID [1]
313662
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
obesity
336232
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overweight
336235
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Condition category
Condition code
Diet and Nutrition
332770
332770
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330261
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Lifestyle
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
340295
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Telomere Length
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Assessment method [1]
340295
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Whole blood samples are collected to analyze Telomere length by Quantitative Polymerase Chain Reaction method.
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Timepoint [1]
340295
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Baseline and 8th week after the intervention begin
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Secondary outcome [1]
443642
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Body composition (total fat percentage, lean muscle percentage, body water) is analyzed by BIA method total fat percentage, lean muscle percentage, body water
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Assessment method [1]
443642
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Bioelectrical impedance analysis (BIA)
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Timepoint [1]
443642
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Baseline, every 2 weeks up to the 8th week post-intervention commencement
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Secondary outcome [2]
443643
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HDL-Cholesterol (HDL-C)
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Assessment method [2]
443643
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Plasma HDL-C levels were assessed by enzymatic colorimetric method
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Timepoint [2]
443643
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Baseline and 8th week post-intervention commencement
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Secondary outcome [3]
444190
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LDL-Cholesterol (LDL-C) and Total Cholesterol (Total-C)
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Assessment method [3]
444190
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Plasma LDL-C and Total-C levels were assessed by photometric method.
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Timepoint [3]
444190
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Baseline and 8th week post-intervention commencement
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Secondary outcome [4]
444191
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Glucose
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Assessment method [4]
444191
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Serum glucose levels were assessed enzymatic colorimetric method
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Timepoint [4]
444191
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Baseline and 8th week post-intervention commencement
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Secondary outcome [5]
444194
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C-reactive protein
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Assessment method [5]
444194
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Serum C-reactive protein levels were assessed by immunoturbidimetric method,
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Timepoint [5]
444194
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Baseline and 8th week post-intervention commencement
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Secondary outcome [6]
444195
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TNF- a
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Assessment method [6]
444195
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Serum TNF-a levels were analyzed by enzyme-linked immunosorbent assay.
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Timepoint [6]
444195
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Baseline and 8th week post-intervention commencement
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Secondary outcome [7]
444196
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IL-6 levels
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Assessment method [7]
444196
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Serum IL-6 levels were analyzed by enzyme-linked immunosorbent assay.
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Timepoint [7]
444196
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Baseline and 8th week post-intervention commencement
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Secondary outcome [8]
444197
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Total antioxidant status (TAS) and Total oxidant status (TOS)
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Assessment method [8]
444197
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Serum Total antioxidant status (TAS) and Total oxidant status (TOS) measurements were done by automated colorimetric method
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Timepoint [8]
444197
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Baseline and 8th week post-intervention commencement
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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.
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Minimum age
20
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
15/02/2021
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Date of last participant enrolment
Anticipated
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Actual
23/02/2022
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Date of last data collection
Anticipated
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Actual
23/05/2022
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Sample size
Target
28
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Accrual to date
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Final
28
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Recruitment outside Australia
Country [1]
26808
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Turkey
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State/province [1]
26808
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Funding & Sponsors
Funding source category [1]
318127
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University
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Name [1]
318127
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Gazi University
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Address [1]
318127
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Country [1]
318127
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Turkey
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Primary sponsor type
University
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Name
Gazi University Scientific Research Projects Unit (BAP)
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Address
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Country
Turkey
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Secondary sponsor category [1]
320511
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None
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Name [1]
320511
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Address [1]
320511
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Country [1]
320511
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316775
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Gazi University Clinical Trials Ethics Committee
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Ethics committee address [1]
316775
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Gazi University, Medicine Faculty, 06500 Besevler/ANKARA/TÜRKIYE
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Ethics committee country [1]
316775
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Turkey
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Date submitted for ethics approval [1]
316775
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15/04/2020
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Approval date [1]
316775
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18/06/2020
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Ethics approval number [1]
316775
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416
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
138974
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Dr Neslihan ARSLAN
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Address
138974
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Health Sciences University, Gülhane Health Sciences Faculty, Nutrition and Dietetics Department, Emrah district 06018 Keçiören ANKARA
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Country
138974
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Turkey
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Phone
138974
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+9005331625286
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Fax
138974
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Email
138974
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[email protected]
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Contact person for public queries
Name
138975
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Ilke Hacer ONEN
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Address
138975
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Gazi University Faculty of Medicine Emniyet District, Mevlana Bulvari No: 29 06500 Yenimahalle/Ankara/Türkiye
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Country
138975
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Turkey
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Phone
138975
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+905426870626
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Fax
138975
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Email
138975
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[email protected]
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Contact person for scientific queries
Name
138976
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Eda KÖKSAL
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Address
138976
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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
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Country
138976
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Turkey
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Phone
138976
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+9005442697939
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Fax
138976
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Email
138976
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
basic results 220125.docx
Documents added automatically
No additional documents have been identified.
Download to PDF