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Completed

NCT Number: NCT05937737

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Internal Medicine Department, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type 2 Diabetes Diet Modification

Behavioral

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

Primary outcomes

  1. Fibroblast growth factor 21 (FGF21)

    Time frame: 12 weeks

    FGF21 levels in serum

  2. Body weight

    Time frame: 12 weeks

    Body weight measurements

  3. Body fat percentage

    Time frame: 12 weeks

    Body fat percentage measured with bioelectrical impedance analysis

  4. Phytochemical index

    Time frame: 12 week

    Dietary phytochemical index

  5. Ferric Reducing Ability of Plasma (FRAP)

    Time frame: 12 weeks

    Dietary antioxidant capacity measured with FRAP method

  6. Oxygen Radical Absorbance Capacity (ORAC)

    Time frame: 12 weeks

    Dietary antioxidant capacity measured with ORAC method

  7. Trolox Equivalent Antioxidant Capacity (TEAC)

    Time frame: 12 weeks

    Dietary antioxidant capacity measured with TEAC method

  8. Total Reactive Antioxidant Potential (TRAP)

    Time frame: 12 weeks

    Dietary antioxidant capacity measured with TRAP method

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 10, 2023
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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