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

29 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

144

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Control
3 main meals and 3 snacks with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
Altro: 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)
Comparatore attivo: 3-meal group
3 main meals only with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
Altro: Three Meal Group
3M: Diet with 3 main meals restricted by 500 kcal from the daily energy requirement
Comparatore attivo: TRF
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.
Altro: Time-restricted eating
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Weight
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Glycated Hemoglobin
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Change from baseline to Week 12.
Measurement of abdominal obesity in centimeters (cm).
Change from baseline to Week 12.
Urinary Albumin/Creatinine Ratio
Lasso di tempo: Change from baseline to Week 12.
Screening for renal health, measured in mg/g creatinine.
Change from baseline to Week 12.
Triglyceride
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Akdeniz University

Investigatori

  • Investigatore principale: Hülya KAMARLI ALTUN, PhD, Associate Professor, Akdeniz University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2024

Completamento primario (Effettivo)

15 novembre 2024

Completamento dello studio (Effettivo)

30 novembre 2024

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TBAEK-121 (Akdeniz University)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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