Intermittent Fasting, Prediabetes, Weight
Conditions
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)
Interventions
BEHAVIORALIntermittent fasting
Eating in a specific hours of days, and being fast on remain of the day.
BEHAVIORALCaloric restriction
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
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight | 5 weeks | weight and height will be combined to report BMI in kg/m\^2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference (WC) | 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. |
| lipid parameters | 5 weeks | After 12 hours fasting, total cholesterol, HDL-C, LDL-C, triglycerides measured in mg. Also TG/HDL-C ratio calculated. |
Countries
Turkey (Türkiye)
Outcome results
None listed