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The Effect of Time-Restricted Eating on Nutritional Status

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05890391
Acronym
TRE
Enrollment
23
Registered
2023-06-06
Start date
2020-01-01
Completion date
2021-05-30
Last updated
2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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

Interventions

OTHERTime-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.

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.

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood total oxidant status8 weeksThe measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Physical Activity Level (PAL)8 weeksPhysical Activity Level (PAL) was determined by physical activity record.
Body weight in kilograms8 weeksBody weight measurement were taken using an Inbody 720 body analyzer.
The energy expenditure in kcal8 weeksResting 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.
Blood cholesterol level8 weeksThe measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
The quality of dietary intake8 weeksDiet quality was assessed with the Healthy Eating Index-2015 (HEI-2015).
Height in meters8 weeksThe height of the individuals was measured with a stadiometer with a sensitivity of 0.1 cm.
waist circumference in meters8 weeksFor 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.
Blood Triglyceride level8 weeksThe measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood fasting glucose level8 weeksThe measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood insulin level8 weeksThe measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood C-reactive protein level8 weeksThe measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood leptin level8 weeksThe measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood adiponectin level8 weeksThe measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood total antioxidant status8 weeksThe measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026