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Serum FGF21 Levels and Dietary Total Antioxidant Capacity in Type 2 Diabetes

The Effect of the Phytochemical Content and Total Antioxidant Capacity of the Diet on Serum FGF21 Levels in Type 2 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05937737
Enrollment
76
Registered
2023-07-10
Start date
2020-04-20
Completion date
2022-04-15
Last updated
2023-07-11

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

Conditions

Type 2 Diabetes

Keywords

FGF-21, type 2 diabetes, antioxidant capacity, phytochemical index

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALType 2 Diabetes Diet Modification

A 12-week dietary intervention model was prescribed to the patients in accordance with their needs.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* For intervention group: type 2 diabetes diagnosis * For control group: healthy individuals * Aged between 19 and 64 * With a body mass index over 25 kg/m²

Exclusion criteria

* Pregnancy * Type 1 diabetes * Cancer * Chronic kidney disease * Chronic liver disease * Other chronic inflammatory diseases * Individuals with HbA1c levels above 9% * Individuals using short or medium-acting or mixed (medium+short) insulin * Individuals with any condition that hinders physical activity * Individuals following any weight loss diet

Design outcomes

Primary

MeasureTime frameDescription
Fibroblast growth factor 21 (FGF21)12 weeksFGF21 levels in serum
Body weight12 weeksBody weight measurements
Body fat percentage12 weeksBody fat percentage measured with bioelectrical impedance analysis
Phytochemical index12 weekDietary phytochemical index
Ferric Reducing Ability of Plasma (FRAP)12 weeksDietary antioxidant capacity measured with FRAP method
Oxygen Radical Absorbance Capacity (ORAC)12 weeksDietary antioxidant capacity measured with ORAC method
Trolox Equivalent Antioxidant Capacity (TEAC)12 weeksDietary antioxidant capacity measured with TEAC method
Total Reactive Antioxidant Potential (TRAP)12 weeksDietary antioxidant capacity measured with TRAP method

Countries

Turkey (Türkiye)

Outcome results

None listed

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