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

NCT07674875 | Completed

• 1 other identifier: TBAEK-121
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Obesity and Overweight

Keywords

weight loss; intermittent fasting; energy restriction; type 2 diabetes; obesity; time-restricted feeding; meal frequency

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  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

Secondary Outcomes (13)

• 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

Study Arms (3)

Control

ACTIVE COMPARATOR

3 main meals and 3 snacks with a 500 kcal/day deficit based on Mifflin-St Jeor equation.

Other: Control Arm - standard of care

3-meal group

ACTIVE COMPARATOR

3 main meals only with a 500 kcal/day deficit based on Mifflin-St Jeor equation.

Other: Three Meal Group

TRF

ACTIVE COMPARATOR

Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.

Other: Time-restricted eating

Interventions

Three Meal Group OTHER

3M: Diet with 3 main meals restricted by 500 kcal from the daily energy requirement

3-meal group

Control Arm - standard of care OTHER

Control Group: 3 main meals and 3 snacks approach routinely applied in the treatment of T2DM (500 kcal restricted from daily energy requirement)

Control

Time-restricted eating OTHER

Ad-libitum feeding within an 8-hour window (12:00-20:00) with 2 main meals and 2 snacks.

TRF

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Faculty of Medicine

Antalya, Konyaalti, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight; Weight Loss; Intermittent Fasting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Fasting; Feeding Behavior; Behavior

Study Officials

• Hülya KAMARLI ALTUN, PhD, Associate Professor

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 30, 2026
• Study Start: March 1, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 30, 2024
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)