An interventional study of Control Arm - standard of care and Three Meal Group in Type 2 Diabetes and Obesity and Overweight, sponsored by Akdeniz University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Akdeniz University · Not applicable, Interventional, and Treatment
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.
This randomized controlled trial investigates the impact of meal frequency and timing on the body composition and metabolic profile of individuals diagnosed with Type 2 Diabetes Mellitus (T2DM). While medical management is a cornerstone of T2DM treatment, dietary patterns, specifically the distribution of meals and fasting windows, may significantly modulate glycemic variability and lipid metabolism.
Methodology and Rationale:
The study follows a three-arm parallel design for 12 weeks. Participants are randomized into Control (6 meals), 3-Meal, or Time-Restricted Eating (TRE) groups using Random Allocation Software.
Energy Expenditure Calculation: For the Control and 3-Meal groups, daily energy requirements are calculated using the Mifflin-St Jeor equation. A 500 kcal/day deficit is applied, ensuring that total energy intake does not fall below the Basal Metabolic Rate (BMR).
Time-Restricted Eating (TRE) Protocol: The TRE group follows an 8-hour eating window (12:00-20:00) consisting of 2 main meals and 2 snacks. Unlike the other groups, no explicit calorie restriction is mandated for the TRE arm, allowing the researchers to observe the spontaneous effects of a restricted feeding window on metabolic parameters.
Dietary Composition: All groups are instructed to follow standard medical nutrition therapy for T2DM, emphasizing high fiber, low saturated fat, and high-quality protein sources.
Sample Size and Statistical Power:
Sample size was estimated based on body weight changes reported in a 12-week time-restricted feeding RCT in overweight adults with type 2 diabetes (Che et al., 2021), which yielded a Cohen's f of 0.40 for between-group differences in body weight. Using one-way ANOVA with α = 0.05 and 80% power (G*Power 3.1), a minimum of 22 participants per group was required for the primary outcome. To also achieve adequate power for the secondary outcome of HbA1c (Cohen's f = 0.35, derived from the same reference), a minimum of 29 participants per group was indicated. Accounting for an anticipated 20% dropout rate, 48 participants per group (144 total) were enrolled
Data Collection and Follow-up:
Anthropometry: Body composition is analyzed monthly using Bioelectrical Impedance Analysis (BIA - Tanita MC 580).
Biochemistry: HbA1c, Fasting Plasma Glucose, Lipid Profile (Total-C, LDL-C, HDL-C, Triglycerides), and Albumin/Creatinine Ratio (UACR) are recorded at baseline and at the end of the 12th week.
Dietary Compliance: Weekly phone calls are conducted to monitor adherence, meal skipping, and protocol deviations. 24-hour dietary recalls are collected at baseline and at the 12th week to verify nutrient intake using professional nutrition software (BeBİS 9.0).
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 144 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
3 main meals and 3 snacks with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
Other: Control Arm - standard of care
3 main meals only with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
Other: Three Meal Group
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.
Other: Time-restricted eating
Control Group: 3 main meals and 3 snacks approach routinely applied in the treatment of T2DM (500 kcal restricted from daily energy requirement)
3M: Diet with 3 main meals restricted by 500 kcal from the daily energy requirement
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.
Change in Body Weight
The primary goal is to evaluate the effect of meal frequency and timing on total body weight. This parameter was used to determine the study's sample size, based on a target of a 5% weight reduction. Measurement is performed in kilograms (kg).
Time frame: From enrollment to the end of treatment at 12 weeks
Glycated Hemoglobin
Evaluation of long-term glycemic control, measured as the percentage (%) of glycated hemoglobin in the blood.
Time frame: Change from baseline to Week 12.
Fasting Plasma Glucose
Concentration of glucose in the blood after an overnight fast, measured in mg/dL.
Time frame: Change from baseline to Week 12.
Waist Circumference
Measurement of abdominal obesity in centimeters (cm).
Time frame: Change from baseline to Week 12.
Urinary Albumin/Creatinine Ratio
Screening for renal health, measured in mg/g creatinine.
Time frame: Change from baseline to Week 12.
Triglyceride
Concentration of triglycerides in the blood after an overnight fast, measured in mg/dL.
Time frame: Week 0 and Week 12
LDL-C
Concentration of low-density lipoprotein (LDL) cholesterol in the blood after an overnight fast, measured in mg/dL.
Time frame: Week 0 and Week 12
HDL-C
Concentration of high-density lipoprotein (HDL) cholesterol in the blood after an overnight fast, measured in mg/dL.
Time frame: Week 0 and Week 12
Total Cholesterol
Concentration of total cholesterol in the blood after an overnight fast, measured in mg/dL.
Time frame: Week 0 and week 12
Body Mass Index
Body mass index calculated from height and weight, measured in kg/m²
Time frame: Week 0 and Week 12
Body Fat Percentage
Percentage of total body fat mass assessed via bioelectrical impedance analysis (BIA), measured in %.
Time frame: Week 0 and week 12
Skeletal Muscle Mass
Total skeletal muscle mass assessed via bioelectrical impedance analysis (BIA), measured in kg.
Time frame: Week 0 and week 12
Fat Mass Index
Fat mass indexed to height squared, assessed via bioelectrical impedance analysis (BIA), measured in kg/m².
Time frame: Week 0 and week 12
Fat Free Mass Index
Fat-free mass indexed to height squared, assessed via bioelectrical impedance analysis (BIA), measured in kg/m²
Time frame: Week 0 and week 12
Plan to share: No — Individual participant data collected during the trial, including biochemical and anthropometric measurements, will not be shared publicly to maintain participant confidentiality and adhere to the Personal Data Protection Law. The data are strictly confidential and belong to the primary research institution. Results will be disseminated through peer-reviewed publications and conference presentations in aggregate form.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Akdeniz University