The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients | NCT07713394

NCT07713394

Overview

NCT ID: NCT07713394
Lead Sponsor: Ataturk UniversityOTHER
Official Title: The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients: A Randomized-Controlled Study
Brief 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)

Status and Timeline

Status: Completed
Last Update Posted: Jul 20, 2026Actual
Start Date: Jan 1, 2023Actual
Primary Completion Date: Dec 31, 2023Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 36Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: Ataturk University

Similar Studies

Participant Group/Arms

Intermittent Fasting (IF)Experimental

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

Control Group (CG)Active Comparator

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