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Meal Frequency and Timing on Metabolic Health in Patients With Type 2 Diabetes

29 de junio de 2026 actualizado por: Hülya Kamarlı Altun, Akdeniz University

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?

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Actual)

144

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Konyaalti
      • Antalya, Konyaalti, Turquía (Türkiye), 07070
        • Akdeniz University Faculty of Medicine

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control
3 main meals and 3 snacks with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
Otro: Control Arm - standard of care
Control Group: 3 main meals and 3 snacks approach routinely applied in the treatment of T2DM (500 kcal restricted from daily energy requirement)
Comparador activo: 3-meal group
3 main meals only with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
Otro: Three Meal Group
3M: Diet with 3 main meals restricted by 500 kcal from the daily energy requirement
Comparador activo: TRF
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.
Otro: Time-restricted eating
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Body Weight
Periodo de tiempo: 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).
From enrollment to the end of treatment at 12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Glycated Hemoglobin
Periodo de tiempo: Change from baseline to Week 12.
Evaluation of long-term glycemic control, measured as the percentage (%) of glycated hemoglobin in the blood.
Change from baseline to Week 12.
Fasting Plasma Glucose
Periodo de tiempo: Change from baseline to Week 12.
Concentration of glucose in the blood after an overnight fast, measured in mg/dL.
Change from baseline to Week 12.
Waist Circumference
Periodo de tiempo: Change from baseline to Week 12.
Measurement of abdominal obesity in centimeters (cm).
Change from baseline to Week 12.
Urinary Albumin/Creatinine Ratio
Periodo de tiempo: Change from baseline to Week 12.
Screening for renal health, measured in mg/g creatinine.
Change from baseline to Week 12.
Triglyceride
Periodo de tiempo: Week 0 and Week 12
Concentration of triglycerides in the blood after an overnight fast, measured in mg/dL.
Week 0 and Week 12
LDL-C
Periodo de tiempo: Week 0 and Week 12
Concentration of low-density lipoprotein (LDL) cholesterol in the blood after an overnight fast, measured in mg/dL.
Week 0 and Week 12
HDL-C
Periodo de tiempo: Week 0 and Week 12
Concentration of high-density lipoprotein (HDL) cholesterol in the blood after an overnight fast, measured in mg/dL.
Week 0 and Week 12
Total Cholesterol
Periodo de tiempo: Week 0 and week 12
Concentration of total cholesterol in the blood after an overnight fast, measured in mg/dL.
Week 0 and week 12
Body Mass Index
Periodo de tiempo: Week 0 and Week 12
Body mass index calculated from height and weight, measured in kg/m²
Week 0 and Week 12
Body Fat Percentage
Periodo de tiempo: Week 0 and week 12
Percentage of total body fat mass assessed via bioelectrical impedance analysis (BIA), measured in %.
Week 0 and week 12
Skeletal Muscle Mass
Periodo de tiempo: Week 0 and week 12
Total skeletal muscle mass assessed via bioelectrical impedance analysis (BIA), measured in kg.
Week 0 and week 12
Fat Mass Index
Periodo de tiempo: Week 0 and week 12
Fat mass indexed to height squared, assessed via bioelectrical impedance analysis (BIA), measured in kg/m².
Week 0 and week 12
Fat Free Mass Index
Periodo de tiempo: Week 0 and week 12
Fat-free mass indexed to height squared, assessed via bioelectrical impedance analysis (BIA), measured in kg/m²
Week 0 and week 12

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Akdeniz University

Investigadores

  • Investigador principal: Hülya KAMARLI ALTUN, PhD, Associate Professor, Akdeniz University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2024

Finalización primaria (Actual)

15 de noviembre de 2024

Finalización del estudio (Actual)

30 de noviembre de 2024

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de junio de 2026

Publicado por primera vez (Actual)

30 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TBAEK-121 (Akdeniz University)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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