An interventional study of Type 2 Diabetes Diet Modification in Type 2 Diabetes, sponsored by Hacettepe University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by Hacettepe University · Not applicable, Interventional, and Screening
This study aimed to evaluate the phytochemicals and total antioxidant capacity in the diets of individuals with type 2 diabetes and assess their relationship with glycemic parameters, as well as certain biochemical parameters and Fibroblast growth factor 21 (FGF21), which is an inflammatory marker. The study was conducted on a total of 80 individuals, including 40 patients with overweight or obesity (Body Mass Index (BMI) > 25 kg/m²) with type 2 diabetes aged between 18 and 64, and 40 healthy controls (BMI between 18.5-35 kg/m²). The individuals were followed for 12 weeks with an appropriate diet. Biochemical parameters, anthropometric measurements, and dietary intake records were monitored at specific intervals throughout the study. The phytochemical index and total antioxidant capacity of the individuals' diets were measured, and FGF21 was examined in the serum.
Individuals were divided into two groups: type 2 diabetes and control. Individuals with type 2 diabetes were followed for 12 weeks with an appropriate diet specific to their condition, and necessary measurements were taken at the beginning, 4th week, and 12th week. No dietary intervention was made for the control group, and necessary measurements were taken at the beginning and 12th week. At the control points, biochemical parameters, serum samples, anthropometric measurements (body composition, weight, height, waist circumference, hip circumference), 24-hour dietary intake record, and 24-hour physical activity record were evaluated. In the experimental group, dietary intake was recorded at the beginning (week 0), 4th week, and 12th week. The dietary intake of the control group was examined at week 0 and week 12.
The "Phytochemical Index" method was used to calculate the total phytochemical intake from the diet. The total antioxidant capacity of the diet was calculated using data obtained from dietary intake records based on Ferric Reducing Ability of Plasma (FRAP), Oxygen Radical Absorbance Capacity (ORAC), Trolox Equivalent Antioxidant Capacity (TEAC), and Total Reactive Antioxidant Potential (TRAP) methods. Additionally, physical activity was determined using a recording method. Body compositions at all three control points will be determined using the bioelectrical impedance method, and waist and hip circumference measurements were taken using a non-stretchable tape measure. Routine biochemical parameters for the type 2 diabetic group (fasting blood glucose, serum lipids, HbA1c) were obtained from the records. Serum samples collected after a 10-12 hour fasting period at the beginning and 12th week were analyzed for Fibroblast growth factor 21 (FGF21) using suitable kits.
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This study's enrollment of 76 is close to the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
Individuals with type 2 diabetes were followed for 12 weeks with an appropriate diet specific to their type 2 diabetes condition, and necessary measurements were taken at the beginning, 4th week, and 12th week.
Behavioral: Type 2 Diabetes Diet Modification
No dietary intervention was made for the control group, and necessary measurements were taken at the beginning and 12th week.
A 12-week dietary intervention model was prescribed to the patients in accordance with their needs.
Fibroblast growth factor 21 (FGF21)
FGF21 levels in serum
Time frame: 12 weeks
Body weight
Body weight measurements
Time frame: 12 weeks
Body fat percentage
Body fat percentage measured with bioelectrical impedance analysis
Time frame: 12 weeks
Phytochemical index
Dietary phytochemical index
Time frame: 12 week
Ferric Reducing Ability of Plasma (FRAP)
Dietary antioxidant capacity measured with FRAP method
Time frame: 12 weeks
Oxygen Radical Absorbance Capacity (ORAC)
Dietary antioxidant capacity measured with ORAC method
Time frame: 12 weeks
Trolox Equivalent Antioxidant Capacity (TEAC)
Dietary antioxidant capacity measured with TEAC method
Time frame: 12 weeks
Total Reactive Antioxidant Potential (TRAP)
Dietary antioxidant capacity measured with TRAP method
Time frame: 12 weeks
Plan to share: No
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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