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Completed
NCT07713394
The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients
Conditions: Prediabetes, Intermittent Fasting, Weight
Sex: Female
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Ataturk University
Location: Ataturk University Erzurum Turkey
Summary
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)
Eligibility Criteria
Inclusion Criteria:
* Female sex
* Age between 18 and 55 years
* Diagnosis of prediabetes (fasting plasma glucose 100-125 mg/dL and/or HbA1c 5.7%-6.4%)
* Willingness and ability to attend in-person dietitian counseling at the Family Health Center Unit and to use WhatsApp for daily follow-up and reporting Provision of written informed consent
Exclusion Criteria:
* Pregnancy or lactation
* Use of antidiabetic or immunosuppressive medications
* Presence of endocrine disorders
* History of malignancy or organ transplantation
* Prior bariatric surgery
Source: ClinicalTrials.gov (NCT07713394). StuddyBuddy aggregates publicly available trial information.