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Completed

NCT Number: NCT05890391

The Effect of Time-Restricted Eating on Nutritional Status

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.

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Key information

Conditions

Energy Expenditure Anthropometric Measure Behavior Biochemical Markers Blood Pressure Fasting Feeding Behavior Healthy Eating Index Intermittent Fasting

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Science

Ankara, 06170, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Body weight in kilograms

    Time frame: 8 weeks

    Body weight measurement were taken using an Inbody 720 body analyzer.

  2. The energy expenditure in kcal

    Time frame: 8 weeks

    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.

  3. Blood cholesterol level

    Time frame: 8 weeks

    The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

  4. The quality of dietary intake

    Time frame: 8 weeks

    Diet quality was assessed with the Healthy Eating Index-2015 (HEI-2015).

  5. Height in meters

    Time frame: 8 weeks

    The height of the individuals was measured with a stadiometer with a sensitivity of 0.1 cm.

  6. waist circumference in meters

    Time frame: 8 weeks

    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.

  7. Blood Triglyceride level

    Time frame: 8 weeks

    The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

  8. Blood fasting glucose level

    Time frame: 8 weeks

    The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

  9. Blood insulin level

    Time frame: 8 weeks

    The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

  10. Blood C-reactive protein level

    Time frame: 8 weeks

    The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

  11. Blood leptin level

    Time frame: 8 weeks

    The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

  12. Blood adiponectin level

    Time frame: 8 weeks

    The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

  13. Blood total antioxidant status

    Time frame: 8 weeks

    The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

  14. Blood total oxidant status

    Time frame: 8 weeks

    The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

  15. Physical Activity Level (PAL)

    Time frame: 8 weeks

    Physical Activity Level (PAL) was determined by physical activity record.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Acronym: TRE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2023
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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