Type 2 DiabetesNCT07674875
Meal Frequency and Timing on Metabolic Health in Patients With Type 2 Diabetes
A study testing Three Meal Group and Time-restricted eating in people with Type 2 Diabetes and Obesity and Overweight, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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)… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Type 2 Diabetes, Obesity and Overweight
- What is being tested?
- Three Meal Group and Time-restricted eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Nov 2024
- 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 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Medicine
Antalya, Konyaalti, 07070
About this study
Official title: The Effects of Meal Frequency and Timing on Lipid Profile, Glycemic Control, and Body Composition in Individuals With Type 2 Diabetes Mellitus: A 12-Week Randomized Controlled Trial
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?
Read more
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.
Read the detailed description
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).
- Conditions
- Type 2 Diabetes, Obesity and Overweight
- Being tested
- Control Arm - standard of care, Three Meal Group, Time-restricted eating
- Keywords
- weight loss, intermittent fasting, energy restriction, type 2 diabetes, obesity, time-restricted feeding, meal frequency
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight, Weight Loss, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Arm - standard of careOther
Control Group: 3 main meals and 3 snacks approach routinely applied in the treatment of T2DM (500 kcal restricted from daily energy requirement)
Three Meal GroupOther
3M: Diet with 3 main meals restricted by 500 kcal from the daily energy requirement
Time-restricted eatingOther
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 3 main meals and 3 snacks with a 500 kcal/day deficit based on Mifflin-St Jeor equation. Receives: Other: Control Arm - standard of care |
| 3-meal group | Active comparator | 3 main meals only with a 500 kcal/day deficit based on Mifflin-St Jeor equation. Receives: Other: Three Meal Group |
| TRF | Active comparator | Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks. Receives: Other: Time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (13)
Glycated Hemoglobin
Evaluation of long-term glycemic control, measured as the percentage (%) of glycated hemoglobin in the blood.
Measured: Change from baseline to Week 12.
Fasting Plasma Glucose
Concentration of glucose in the blood after an overnight fast, measured in mg/dL.
Measured: Change from baseline to Week 12.
Waist Circumference
Measurement of abdominal obesity in centimeters (cm).
Measured: Change from baseline to Week 12.
Urinary Albumin/Creatinine Ratio
Screening for renal health, measured in mg/g creatinine.
Measured: Change from baseline to Week 12.
Triglyceride
Concentration of triglycerides in the blood after an overnight fast, measured in mg/dL.
Measured: 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.
Measured: 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.
Measured: Week 0 and Week 12
Total Cholesterol
Concentration of total cholesterol in the blood after an overnight fast, measured in mg/dL.
Measured: Week 0 and week 12
Body Mass Index
Body mass index calculated from height and weight, measured in kg/m²
Measured: Week 0 and Week 12
Body Fat Percentage
Percentage of total body fat mass assessed via bioelectrical impedance analysis (BIA), measured in %.
Measured: Week 0 and week 12
Skeletal Muscle Mass
Total skeletal muscle mass assessed via bioelectrical impedance analysis (BIA), measured in kg.
Measured: Week 0 and week 12
Fat Mass Index
Fat mass indexed to height squared, assessed via bioelectrical impedance analysis (BIA), measured in kg/m².
Measured: 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
Measured: Week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Mar 2024
- Primary completion15 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Kamarlı Altun, Akdeniz University
- Investigators
- Hülya KAMARLI ALTUN, PhD, Associate Professor, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674875
- Sponsor's protocol ID
- TBAEK-121
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Meal Frequency and Timing on Lipid Profile, Glycemic Control, and Body Composition in Individuals With Type 2 Diabetes Mellitus: A 12-Week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07674875
- Acronym / sponsor ID
- TBAEK-121
- Conditions
- Type 2 Diabetes, Obesity and Overweight
- Keywords
- weight loss, intermittent fasting, energy restriction, type 2 diabetes, obesity, time-restricted feeding, meal frequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 30 Jun 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 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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control Arm - standard of care3 main meals and 3 snacks with a 500 kcal/day deficit based on Mifflin-St Jeor equation. |
| 3-meal group | Active comparator | Other: Three Meal Group3 main meals only with a 500 kcal/day deficit based on Mifflin-St Jeor equation. |
| TRF | Active comparator | Other: Time-restricted eatingAd-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
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 |
|---|---|---|
| Control Arm - standard of careControl Group: 3 main meals and 3 snacks approach routinely applied in the treatment of T2DM (500 kcal restricted from daily energy requirement) | Other | Control |
| Three Meal Group3M: Diet with 3 main meals restricted by 500 kcal from the daily energy requirement | Other | 3-meal group |
| Time-restricted eatingAd-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks. | Other | TRF |
Primary outcome
Change in Body Weight
Time frame: From enrollment to the end of treatment at 12 weeks
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).
13 secondary outcomes
Glycated Hemoglobin
Time frame: Change from baseline to Week 12.
Fasting Plasma Glucose
Time frame: Change from baseline to Week 12.
Waist Circumference
Time frame: Change from baseline to Week 12.
Urinary Albumin/Creatinine Ratio
Time frame: Change from baseline to Week 12.
Triglyceride
Time frame: Week 0 and Week 12
LDL-C
Time frame: Week 0 and Week 12
HDL-C
Time frame: Week 0 and Week 12
Total Cholesterol
Time frame: Week 0 and week 12
Body Mass Index
Time frame: Week 0 and Week 12
Body Fat Percentage
Time frame: Week 0 and week 12
Skeletal Muscle Mass
Time frame: Week 0 and week 12
Fat Mass Index
Time frame: Week 0 and week 12
Fat Free Mass Index
Time frame: Week 0 and week 12
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 30 Jun 2026.
- Individual participant dataSharing planned: 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.
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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.
Hülya KAMARLI ALTUN, PhD, Associate Professor principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three Meal Group and Time-restricted eating in people with Type 2 Diabetes and Obesity and Overweight, run by Akdeniz 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 5 inclusion and 10 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 30 Jun 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?
Change in Body Weight (time frame: From enrollment to the end of treatment at 12 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 30 Jun 2026.