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Completed
NCT07674875
Meal Frequency and Timing on Metabolic Health in Patients With Type 2 Diabetes
Conditions: Type 2 Diabetes, Obesity and Overweight
Sex: All
Ages: 19 Years – 64 Years
Healthy volunteers: No
Phase: NA
Enrollment: 144
Sponsor: Akdeniz University
Location: Akdeniz University Faculty of Medicine Antalya Konyaalti
Summary
The goal of this clinical trial is to learn if changing when and how often people eat works to improve health in adults with Type 2 diabetes. The main questions it aims to answer are:
How do these eating patterns change body weight and body fat?
Does changing meal timing and frequency lower blood sugar levels (HbA1c) over 12 weeks?
Does it lower blood fat levels, such as cholesterol and triglycerides?
Researchers will compare three groups to see which eating pattern works best:
Standard Group: Participants eat 3 main meals and 3 snacks (6 times total) each day with a calorie limit.
3-Meal Group: Participants eat only 3 main meals each day with a calorie limit.
Time-Restricted Group: Participants eat all their daily food within an 8-hour window (from 12:00 to 20:00) without a calorie limit.
Participants will:
Follow their assigned eating plan for 12 weeks.
Visit the clinic once every month for checkups and body measurements.
Give blood samples at the start and end of the study for laboratory tests.
Record the food they eat and their physical activity levels.
Eligibility Criteria
Inclusion Criteria:
* Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 6 months.
* Aged between 18 and 65 years.
* Residing in Antalya, Turkey (to ensure regular follow-up visits).
* Able and willing to provide informed consent.
* Willing to comply with the assigned dietary protocol and follow-up measurements for 12 weeks.
Exclusion Criteria:
* Diagnosis of Type 1 Diabetes Mellitus or other specific types of diabetes.
* Current pregnancy or breastfeeding.
* Working in night shifts or irregular schedules (due to interference with Time-Restricted Eating protocols).
* Having a history of major cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months.
* Severe renal or hepatic impairment (e.g., Stage 4 or 5 Chronic Kidney Disease).
* Active malignancy or other chronic diseases that may significantly affect nutritional status.
* Significant weight change (more than 5% of body weight) within the last 3 months prior to the study.
* Use of medications that may significantly affect body weight or metabolism other than standard diabetes medications (e.g., systemic corticosteroids).
* History of major gastrointestinal surgery that affects nutrient absorption.
* Severe psychiatric disorders that may limit the ability to follow the study instructions.
Source: ClinicalTrials.gov (NCT07674875). StuddyBuddy aggregates publicly available trial information.