CompletedNot Applicable

The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients

Turkey (Türkiye)36 participantsStarted 2023-01-01

Plain-language 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)

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

weight

Timeframe: 5 weeks

Trial details

NCT IDNCT07713394

SponsorAtaturk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Prediabetes trials