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

2026年6月29日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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).

研究类型

介入性

注册 (实际的)

144

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
    • Konyaalti
      • Antalya、Konyaalti、土耳其（türkiye）、07070
        • Akdeniz University Faculty of Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control
3 main meals and 3 snacks with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
其他：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)
有源比较器：3-meal group
3 main meals only with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
其他：Three Meal Group
3M: Diet with 3 main meals restricted by 500 kcal from the daily energy requirement
有源比较器：TRF
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.
其他：Time-restricted eating
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Body Weight
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Glycated Hemoglobin
大体时间：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
大体时间：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
大体时间：Change from baseline to Week 12.
Measurement of abdominal obesity in centimeters (cm).
Change from baseline to Week 12.
Urinary Albumin/Creatinine Ratio
大体时间：Change from baseline to Week 12.
Screening for renal health, measured in mg/g creatinine.
Change from baseline to Week 12.
Triglyceride
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Akdeniz University

调查人员

  • 首席研究员：Hülya KAMARLI ALTUN, PhD, Associate Professor、Akdeniz University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年3月1日

初级完成 (实际的)

2024年11月15日

研究完成 (实际的)

2024年11月30日

研究注册日期

首次提交

2026年6月17日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年6月30日

研究记录更新

最后更新发布 (实际的)

2026年6月30日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TBAEK-121 (Akdeniz University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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药物干预

膳食补充剂

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