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

2026년 6월 29일 업데이트: 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.

연구 개요

상태

완전한

정황

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

중재적

등록 (실제)

144

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

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

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Control
3 main meals and 3 snacks with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
다른: 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)
활성 비교기: 3-meal group
3 main meals only with a 500 kcal/day deficit based on Mifflin-St Jeor equation.
다른: Three Meal Group
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.
다른: Time-restricted eating
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

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

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

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Akdeniz University

수사관

  • 수석 연구원: Hülya KAMARLI ALTUN, PhD, Associate Professor, Akdeniz University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 3월 1일

기본 완료 (실제)

2024년 11월 15일

연구 완료 (실제)

2024년 11월 30일

연구 등록 날짜

최초 제출

2026년 6월 17일

QC 기준을 충족하는 최초 제출

2026년 6월 29일

처음 게시됨 (실제)

2026년 6월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 29일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TBAEK-121 (Akdeniz University)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

제2형 당뇨병에 대한 임상 시험

Control Arm - standard of care에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Israel

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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