The Effect of Time-Restricted Eating on Nutritional Status (TRE)

Time-Restricted Eating (16/8) and Energy-Restricted Diet: Effects on Diet Quality, Body Composition and Biochemical Parameters in Healthy Overweight Females

This study was planned to investigate the effect of TRE on the nutritional status and diet quality of individuals and to compare the effects of TRE and energy-restricted diet (ERD) in healthy overweight individuals. The female individuals were randomly divided into the TRE or ERD groups in an unbiased manner using a computer-generated block randomisation list. Individuals in the TRE group applied a diet limited to 8 hours for 8 weeks (16/8). They were fed ad libitum between 10.00 a.m-06.00 p.m and fasted between 06.00 p.m-10.00 a.m.No restrictions were imposed on the type and amount of food consumed during the feeding period. During the fasting period, individuals consumed water and non-energy drinks (tea, coffee, soda, etc.). Individuals in the ERD group followed a diet specially prepared for them for 8 weeks. At the first encounter with individuals, resting energy expenditure (REE) was measured by the indirect calorimetry method. Physical Activity Level (PAL) was determined by physical activity record. The total energy expenditure (TEE) of individuals was determined using the 'REE x PAL' formulation. 'TEE-500 kcal' formulation was used for the diet to be given to individuals. Individuals were not given a diet containing energy below the REE. Acceptable macronutrient distribution range (AMDR) were taken as dietary content. The diet given to individuals has 45-65% carbohydrate, 20-35% fat, 10-35% protein content. Nutritional habits of individuals were taken into consideration while planning the diet. Each individual consumed 3 main meals and the number of snacks was determined individually. Food exchange lists were given to individuals and nutrient changes were explained in detail. Anthropometric and body composition measurements of individuals were taken. The energy expenditure was measured using indirect calorimetry. Blood pressure and heart rate measurements were made. Biochemical parameters were evaluated and food consumption were taken. The quality of dietary intake was assessed using the Healthy Eating Index (HEI) -2015.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Biochemical Markers; Energy Expenditure; Healthy Eating Index; Anthropometric Measure
• Intervention / Treatment: Other: Time-Restricted Eating; Other: Energy-Restricted Diet

Detailed Description

The female individuals were randomly divided into the TRE or ERD groups in an unbiased manner using a computer-generated block randomisation list.

Individuals in the TRE group applied a diet limited to 8 hours for 8 weeks (16/8). They were fed ad libitum between 10.00 a.m-06.00 p.m and fasted between 06.00 p.m-10.00 a.m. No restrictions were imposed on the type and amount of food consumed during the feeding period.

Individuals in the ERD group followed a diet specially prepared for them for 8 weeks. At the first encounter with individuals, resting energy expenditure (REE) was measured by the indirect calorimetry method. Physical Activity Level (PAL) was determined by physical activity record. The total energy expenditure (TEE) of individuals was determined using the 'REE x PAL' formulation. 'TEE-500 kcal' formulation was used for the diet to be given to individuals. Individuals were not given a diet containing energy below the REE. Acceptable macronutrient distribution range (AMDR) were taken as dietary content. The diet given to individuals has 45-65% carbohydrate, 20-35% fat, 10-35% protein content. Nutritional habits of individuals were taken into consideration while planning the diet. Each individual consumed 3 main meals and the number of snacks was determined individually. Food exchange lists were given to individuals and nutrient changes were explained in detail.

Parameters to be evaluated at the beginning and end of the study

Anthropometric and body composition measurements The energy expenditure Blood pressure and heart rate measurements Biochemical parameters Food consumption The quality of dietary intake

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06170
    • Faculty of Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Consent form was signed by the individuals who accepted the study.

Exclusion Criteria:

• Individuals who smoke, who are pregnant, lactating and who are in the postmenopausal period, who take hormone therapy, who have followed any diet program for the last 3 months before the study, and who use vitamin/mineral supplementation were not included in the study.

Individuals who wanted to increase their physical activity level in addition to the applied diet were not included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time-Restricted Eating; Individuals in the TRE group applied a diet limited to 8 hours for 8 weeks.	Other: Time-Restricted Eating; They were fed ad libitum between 10.00 a.m-06.00 p.m and fasted between 06.00 p.m-10.00 a.m.
Experimental: Energy-Restricted Diet; Individuals in the ERD group followed a diet specially prepared for them for 8 weeks.	Other: Energy-Restricted Diet; The total energy expenditure (TEE) of individuals was determined using the 'Resting Energy Expenditure (REE) x Physical Activity Level (PAL) ' formulation. 'TEE-500 kcal' formulation was used for the diet to be given to individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight in kilograms	Body weight measurement were taken using an Inbody 720 body analyzer.	8 weeks
The energy expenditure in kcal	Resting energy expenditure was measured at the beginning and end of the study using indirect calorimetry (COSMED, FitMatePro, Rome, Italy). Measurements were taken in the early morning hours after at least 8 hours of fasting.	8 weeks
Blood cholesterol level	The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.	8 weeks
The quality of dietary intake	Diet quality was assessed with the Healthy Eating Index-2015 (HEI-2015).	8 weeks
Height in meters	The height of the individuals was measured with a stadiometer with a sensitivity of 0.1 cm.	8 weeks
waist circumference in meters	For waist circumference measurement, the midpoint between the lowest rib bone and the cristailiac was found, and the circumference measurement passing through this point was taken.	8 weeks
Blood Triglyceride level	The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.	8 weeks
Blood fasting glucose level	The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.	8 weeks
Blood insulin level	The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.	8 weeks
Blood C-reactive protein level	The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.	8 weeks
Blood leptin level	The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.	8 weeks
Blood adiponectin level	The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.	8 weeks
Blood total antioxidant status	The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.	8 weeks
Blood total oxidant status	The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.	8 weeks
Physical Activity Level (PAL)	Physical Activity Level (PAL) was determined by physical activity record.	8 weeks

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: ÖZGE MENGİ ÇELİK, University of Health science

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: body composition; time-restricted eating; biochemical parameters; diet quality
• Other Study ID Numbers: 86/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No