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临床试验/NCT05937737
NCT05937737已完成不适用

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

Hacettepe University4 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2020年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
4
主要终点
Phytochemical index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
19 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnancy
  • Type 1 diabetes
  • 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

结局指标

主要结局

Phytochemical index

时间窗: 12 week

Dietary phytochemical index

Body fat percentage

时间窗: 12 weeks

Body fat percentage measured with bioelectrical impedance analysis

Oxygen Radical Absorbance Capacity (ORAC)

时间窗: 12 weeks

Dietary antioxidant capacity measured with ORAC method

Fibroblast growth factor 21 (FGF21)

时间窗: 12 weeks

FGF21 levels in serum

Body weight

时间窗: 12 weeks

Body weight measurements

Ferric Reducing Ability of Plasma (FRAP)

时间窗: 12 weeks

Dietary antioxidant capacity measured with FRAP method

Total Reactive Antioxidant Potential (TRAP)

时间窗: 12 weeks

Dietary antioxidant capacity measured with TRAP method

Trolox Equivalent Antioxidant Capacity (TEAC)

时间窗: 12 weeks

Dietary antioxidant capacity measured with TEAC method

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep Goktas

Principal Investigator

Hacettepe University

研究点 (4)

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