The Effect of Time-Restricted Eating on Nutritional Status

Blood Pressure Clinical Trial

— TRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05890391
• Other study ID #: 86/2019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: May 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anthropometric Measure
• Biochemical Markers
• Blood Pressure
• Energy Expenditure

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Faculty of Health Science	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight in kilograms	Body weight measurement were taken using an Inbody 720 body analyzer.	8 weeks
Primary	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
Primary	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
Primary	The quality of dietary intake	Diet quality was assessed with the Healthy Eating Index-2015 (HEI-2015).	8 weeks
Primary	Height in meters	The height of the individuals was measured with a stadiometer with a sensitivity of 0.1 cm.	8 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Physical Activity Level (PAL)	Physical Activity Level (PAL) was determined by physical activity record.	8 weeks