An interventional study of Intermittent fasting and Caloric restriction in Prediabetes, Intermittent Fasting and Weight, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Ataturk University · Not applicable, Interventional, and Treatment
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)
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 36 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the IF group followed a time-restricted eating schedule, consuming all meals within an 8-hour window (10:00 AM-6:00 PM), with a fasting period of 16 hours daily. To facilitate adherence and minimize side effects, the fasting duration was gradually increased over the first 6 days (12 hours for Days 1-3, 14 hours for Days 4-6), then maintained at 16 hours for the remaining 4 weeks. Diets were customized to individual energy needs and divided into 2-3 meals during the feeding window. Participants received daily reminders and support via WhatsApp, and were encouraged to report their food intake and physical activity.
Behavioral: Intermittent fasting
The CG 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. Diet content matched that of the IF group in terms of energy deficit and macronutrient composition. Participants received daily follow-up and education similar to the IF group.
Behavioral: Caloric restriction
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
weight
weight and height will be combined to report BMI in kg/m\^2
Time frame: 5 weeks
Waist circumference (WC)
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
lipid parameters
After 12 hours fasting, total cholesterol, HDL-C, LDL-C, triglycerides measured in mg. Also TG/HDL-C ratio calculated.
Time frame: 5 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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