The Effect of Time-Restricted Eating on Nutritional Status

NCT05890391 | Completed

• 1 other identifier: 86/2019
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Energy Expenditure; Anthropometric Measure; Blood Pressure; Biochemical Markers; Healthy Eating Index

Keywords

time-restricted eating; diet quality; body composition; biochemical parameters

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

Time-Restricted Eating

EXPERIMENTAL

Individuals in the TRE group applied a diet limited to 8 hours for 8 weeks.

Other: Time-Restricted Eating

Energy-Restricted Diet

EXPERIMENTAL

Individuals in the ERD group followed a diet specially prepared for them for 8 weeks.

Other: Energy-Restricted Diet

Interventions

Time-Restricted Eating OTHER

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.

Time-Restricted Eating

Energy-Restricted Diet OTHER

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.

Energy-Restricted Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Faculty of Health Science

Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• ÖZGE MENGİ ÇELİK

  University of Health science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

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

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 6, 2023
• Study Start: January 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: June 6, 2023

Record last verified: 2023-05

Locations

TU (1)