Ataturk University
Erzurum, Turkey, 25040, Turkey (Türkiye)
NCT Number: NCT07713394
The goal of this randomized controlled trial is to learn about the short-term effects of an 8-hour time-restricted eating (TRE) protocol combined with caloric restriction in women aged 18-55 years with prediabetes.
The main question it aims to answer is:
Does an 8-hour time-restricted eating protocol combined with caloric restriction improve anthropometric measurements and metabolic parameters more than caloric restriction alone in women with prediabetes?
Researchers will compare the time-restricted eating (IF) group to a control group following a conventional calorie-restricted diet with no time restriction, to see whether time-restricted eating provides additional benefit beyond that of caloric deficit alone.
Participants will:
Be randomly assigned to either the IF group (all meals consumed within an 8-hour window, 16-hour daily fast) or the control group (calorie-restricted diet, no time restriction), both matched for a 500 kcal/day energy deficit Follow their assigned diet for 5 weeks, with daily dietary reminders and support Undergo assessments at baseline and at the end of the 5-week intervention, including body weight, BMI, waist/hip circumference, body composition (bioimpedance), and fasting blood tests (glucose, insulin, HbA1c, total cholesterol, HDL-C, LDL-C, triglycerides)
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Notify Me18 year–55 year
Female
Interventional
Not applicable
Erzurum, Turkey, 25040, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eating in a specific hours of days, and being fast on remain of the day.
The participants followed a conventional hypocaloric diet with no time restriction. Their meals were distributed over 5-6 eating occasions throughout the day, spaced at 3-3.5 hour intervals
Time frame: 5 weeks
weight and height will be combined to report BMI in kg/m^2
Time frame: 5 weeks
Waist circumference will be measured in centimeters using a non-stretch tape measure. Waist circumference measured in centimeters using a non-stretch tape measure.
Time frame: 5 weeks
After 12 hours fasting, total cholesterol, HDL-C, LDL-C, triglycerides measured in mg. Also TG/HDL-C ratio calculated.
Ataturk University
Other
The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients: A Randomized-Controlled Study
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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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