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临床试验/NCT05890391
NCT05890391已完成不适用

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

Saglik Bilimleri Universitesi2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
The energy expenditure in kcal

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

The energy expenditure in kcal

时间窗: 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.

waist circumference in meters

时间窗: 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

时间窗: 8 weeks

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

Blood insulin level

时间窗: 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 fasting glucose level

时间窗: 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

时间窗: 8 weeks

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

Blood cholesterol level

时间窗: 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)

时间窗: 8 weeks

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

The quality of dietary intake

时间窗: 8 weeks

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

Blood Triglyceride level

时间窗: 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 adiponectin level

时间窗: 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

时间窗: 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 leptin level

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Özge Mengi Çelik

assistant professor

Saglik Bilimleri Universitesi

研究点 (2)

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