PrediabetesNCT07713394
The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients
A study testing Intermittent fasting and Caloric restriction in people with Prediabetes and Intermittent Fasting, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Prediabetes, Intermittent Fasting, Weight
- What is being tested?
- Intermittent fasting and Caloric restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation
- Use of antidiabetic or immunosuppressive medications
- Presence of endocrine disorders
- History of malignancy or organ transplantation
- Prior bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients: A Randomized-Controlled Study
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:
Read more
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)
- Conditions
- Prediabetes, Intermittent Fasting, Weight
- Being tested
- Intermittent fasting, Caloric restriction
- Medical subject headings
- Prediabetic State, Intermittent Fasting, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastingBehavioural
Eating in a specific hours of days, and being fast on remain of the day.
Caloric restrictionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
weight and height will be combined to report BMI in kg/m^2
Measured: 5 weeks
Secondary outcomes (2)
Waist circumference (WC)
Waist circumference will be measured in centimeters using a non-stretch tape measure. Waist circumference measured in centimeters using a non-stretch tape measure.
Measured: 5 weeks
lipid parameters
After 12 hours fasting, total cholesterol, HDL-C, LDL-C, triglycerides measured in mg. Also TG/HDL-C ratio calculated.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Cayir, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713394
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/699
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intermittent Fasting on Anthropometric Measurements and Metabolic Parameters in Prediabetic Patients: A Randomized-Controlled Study
- ClinicalTrials.gov ID
- NCT07713394
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/699
- Conditions
- Prediabetes, Intermittent Fasting, Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting (IF) | Experimental | Behavioral: Intermittent fastingParticipants 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. |
| Control Group (CG) | Active comparator | Behavioral: Caloric restrictionThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Use of antidiabetic or immunosuppressive medications
- Presence of endocrine disorders
- History of malignancy or organ transplantation
- Prior bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent fastingEating in a specific hours of days, and being fast on remain of the day. | Behavioural | Intermittent Fasting (IF) |
| Caloric restrictionThe 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 | Behavioural | Control Group (CG) |
Primary outcome
weight
Time frame: 5 weeks
weight and height will be combined to report BMI in kg/m^2
2 secondary outcomes
Waist circumference (WC)
Time frame: 5 weeks
lipid parameters
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent fasting and Caloric restriction in people with Prediabetes and Intermittent Fasting, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.