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OpenTrials
Completed

NCT Number: NCT07713394

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

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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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, Turkey, 25040, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent fasting

Behavioral

Eating in a specific hours of days, and being fast on remain of the day.

Caloric restriction

Behavioral

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

Primary outcomes

  1. weight

    Time frame: 5 weeks

    weight and height will be combined to report BMI in kg/m^2

Secondary outcomes

  1. Waist circumference (WC)

    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.

  2. lipid parameters

    Time frame: 5 weeks

    After 12 hours fasting, total cholesterol, HDL-C, LDL-C, triglycerides measured in mg. Also TG/HDL-C ratio calculated.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients: A Randomized-Controlled Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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