NCT05937737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

June 21, 2023

Last Update Submit

July 10, 2023

Conditions

Type 2 Diabetes

Keywords

FGF-21type 2 diabetesantioxidant capacityphytochemical index

Outcome Measures

Primary Outcomes (8)

  • Fibroblast growth factor 21 (FGF21)

    FGF21 levels in serum

    12 weeks

  • Body weight

    Body weight measurements

    12 weeks

  • Body fat percentage

    Body fat percentage measured with bioelectrical impedance analysis

    12 weeks

  • Phytochemical index

    Dietary phytochemical index

    12 week

  • Ferric Reducing Ability of Plasma (FRAP)

    Dietary antioxidant capacity measured with FRAP method

    12 weeks

  • Oxygen Radical Absorbance Capacity (ORAC)

    Dietary antioxidant capacity measured with ORAC method

    12 weeks

  • Trolox Equivalent Antioxidant Capacity (TEAC)

    Dietary antioxidant capacity measured with TEAC method

    12 weeks

  • Total Reactive Antioxidant Potential (TRAP)

    Dietary antioxidant capacity measured with TRAP method

    12 weeks

Study Arms (2)

Type 2 Diabetes

EXPERIMENTAL

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

Healthy Controls

NO INTERVENTION

No dietary intervention was made for the control group, and necessary measurements were taken at the beginning and 12th week.

Interventions

Type 2 Diabetes Diet ModificationBEHAVIORAL

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

Type 2 Diabetes

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hacettepe University Internal Medicine Department

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Nutrition and Dietetics Department

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Zeynep Goktas, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 10, 2023

Study Start

April 20, 2020

Primary Completion

December 30, 2021

Study Completion

April 15, 2022

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)