Meal Frequency and Timing on Metabolic Health in Patients With Type 2 Diabetes
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Konyaalti
-
Antalya, Konyaalti, 터키 (Türkiye), 07070
- Akdeniz University Faculty of Medicine
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: Control
3 main meals and 3 snacks with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
|
Control Group: 3 main meals and 3 snacks approach routinely applied in the treatment of T2DM (500 kcal restricted from daily energy requirement)
|
|
활성 비교기: 3-meal group
3 main meals only with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
|
3M: Diet with 3 main meals restricted by 500 kcal from the daily energy requirement
|
|
활성 비교기: TRF
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.
|
Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Body Weight
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Glycated Hemoglobin
기간: 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
기간: 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
기간: Change from baseline to Week 12.
|
Measurement of abdominal obesity in centimeters (cm).
|
Change from baseline to Week 12.
|
|
Urinary Albumin/Creatinine Ratio
기간: Change from baseline to Week 12.
|
Screening for renal health, measured in mg/g creatinine.
|
Change from baseline to Week 12.
|
|
Triglyceride
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Hülya KAMARLI ALTUN, PhD, Associate Professor, Akdeniz University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- TBAEK-121 (Akdeniz University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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