The Effect of Time-Restricted Eating on Nutritional Status
- Conditions
- Anthropometric MeasureBlood PressureBiochemical MarkersHealthy Eating IndexEnergy Expenditure
- Registration Number
- NCT05890391
- Lead Sponsor
- Saglik Bilimleri Universitesi
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 23
- Consent form was signed by the individuals who accepted the study.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Blood leptin level 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.
Blood total oxidant status 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.
The energy expenditure in kcal 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.
Blood fasting glucose level 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.
waist circumference in meters 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.
Height in meters 8 weeks The height of the individuals was measured with a stadiometer with a sensitivity of 0.1 cm.
Blood insulin level 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.
Body weight in kilograms 8 weeks Body weight measurement were taken using an Inbody 720 body analyzer.
Blood adiponectin level 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.
Blood C-reactive protein level 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.
Blood total antioxidant status 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.
Blood cholesterol level 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.
Physical Activity Level (PAL) 8 weeks Physical Activity Level (PAL) was determined by physical activity record.
The quality of dietary intake 8 weeks Diet quality was assessed with the Healthy Eating Index-2015 (HEI-2015).
Blood Triglyceride level 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of Health Science
🇹🇷Ankara, Turkey
Faculty of Health Science🇹🇷Ankara, Turkey