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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Body Weight
时间窗: 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).
次要结局
- Glycated Hemoglobin(Change from baseline to Week 12.)
- Fasting Plasma Glucose(Change from baseline to Week 12.)
- Waist Circumference(Change from baseline to Week 12.)
- Urinary Albumin/Creatinine Ratio(Change from baseline to Week 12.)
- Triglyceride(Week 0 and Week 12)
- LDL-C(Week 0 and Week 12)
- HDL-C(Week 0 and Week 12)
- Total Cholesterol(Week 0 and week 12)
- Body Mass Index(Week 0 and Week 12)
- Body Fat Percentage(Week 0 and week 12)
- Skeletal Muscle Mass(Week 0 and week 12)
- Fat Mass Index(Week 0 and week 12)
- Fat Free Mass Index(Week 0 and week 12)
研究者
Hülya Kamarlı Altun
Associate Professor
Akdeniz University