Clinical trial NCT05890391: The Effect of Time-Restricted Eating on Nutritional Status
Official title: Time-Restricted Eating (16/8) and Energy-Restricted Diet: Effects on Diet Quality, Body Composition and Biochemical Parameters in Healthy Overweight Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Expenditure
Anthropometric Measure
Blood Pressure
Biochemical Markers
Healthy Eating Index
Keywords: time-restricted eating
diet quality
body composition
biochemical parameters
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight in kilograms
timeFrame: 8 weeks
measure: The energy expenditure in kcal
timeFrame: 8 weeks
measure: Blood cholesterol level
timeFrame: 8 weeks
measure: The quality of dietary intake
timeFrame: 8 weeks
measure: Height in meters
timeFrame: 8 weeks
measure: waist circumference in meters
timeFrame: 8 weeks
measure: Blood Triglyceride level
timeFrame: 8 weeks
measure: Blood fasting glucose level
timeFrame: 8 weeks
measure: Blood insulin level
timeFrame: 8 weeks
measure: Blood C-reactive protein level
timeFrame: 8 weeks
measure: Blood leptin level
timeFrame: 8 weeks
measure: Blood adiponectin level
timeFrame: 8 weeks
measure: Blood total antioxidant status
timeFrame: 8 weeks
measure: Blood total oxidant status
timeFrame: 8 weeks
measure: Physical Activity Level (PAL)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Faculty of Health Science
Study officials:
affiliation: University of Health science
name: ÖZGE MENGİ ÇELİK
role: PRINCIPAL_INVESTIGATOR
References: