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临床试验/NCT07055620
NCT07055620已完成不适用

Effects of Different Dietary Models on Eating Behavior and Obesity Management in Overweight and Obese Individuals: A Randomized Controlled Trial

Selcuk University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Diet Satisfaction Scale

研究概览

简要总结

The aim of this study is to examine the effects of different diet models (Mediterranean diet, time-restricted feeding and standard diet application) applied to overweight and obese individuals on eating behavior and obesity management.

Sub-objectives can be listed as; Effects of different diet models on body composition, Effects of different diet models on dietary intake, Effects of different diet models on biochemical parameters (such as blood sugar, insulin resistance, lipid profile).

As a result, this study aims to contribute to the development of individualized nutrition counseling programs by determining effective diet strategies in obesity.

详细描述

Overweight and obesity are among the most significant risk factors for health globally, with more than 1 billion people expected to be obese by 2030. Turkey is projected to be among the countries at high risk of obesity by 2030. Furthermore, obesity is among the preventable risk factors for cardiovascular disease (CVD), cancer, diabetes, stroke, and chronic lung disease, among other noncommunicable diseases (NCDs). Overweight and obesity are widespread and increasing health problems worldwide. Excessive adiposity is associated with insulin resistance, lipid deterioration, and systemic inflammation. A 5-10% weight loss is known to improve metabolic outcomes such as blood sugar, lipid profile, and blood pressure. Individuals employ a variety of strategies to lose weight. Lifestyle interventions that encourage calorie restriction and increased physical activity are the most commonly prescribed interventions by healthcare and clinical practitioners. While continuous energy restriction is a more traditional method for reducing energy intake, intermittent fasting has emerged as a potential alternative in the last decade. Fasting is known as one of the world's oldest traditions and is practiced across various communities for cultural or religious reasons. Fasting has also been used as a treatment for illness in the past. Hippocrates, considered the father of modern medicine, emphasized the importance of fasting during illness with the saying, "Eating when you are sick is feeding your illness." Intermittent fasting (IF), or periods of voluntary abstinence from food and drink, is an ancient practice followed in various forms by many populations worldwide. Intermittent fasting involves fasting or restricting food intake for specific hours of the day or on specific days of the week. IF can be implemented in three different ways: alternate-day fasting, the 5:2 diet, and time-restricted feeding (TRF). Alternate-day fasting involves alternating days of food and drink consumption with days of fasting during which no energy-containing food or drink is consumed. In alternate-day fasting, approximately 20-25% of energy needs are met on fasting days. Modified fasting is also known as the 5:2 method. This eating pattern involves a very low-calorie diet for two non-consecutive days per week, followed by normal energy requirements without energy restriction for the other five days. Another approach, time-restricted feeding (TRF), is used to describe an eating pattern in which food intake is restricted to a time window of 8 hours or less each day. Among intermittent fasting diets, the TRF diet is a lifestyle intervention that restricts food intake to a fixed number of hours. Welton and colleagues reported that the ideal fasting period for positive weight change is 16 hours. In recent years, small-scale human studies demonstrating the importance of time-restricted eating have become widespread. Many of these studies, as in animal studies, have demonstrated the beneficial effects of intermittent fasting on human metabolism. TRF has been found to reduce energy intake, body weight, body fat, blood glucose, triglycerides, glucose tolerance, and inflammatory markers. It has been established that IF may be beneficial in reducing body weight, improving insulin resistance, and reducing infection by regulating circadian rhythms, gut microbial composition, and metabolism. Time-restricted eating has been suggested as a potential weight-loss strategy because it may be more acceptable due to the reduced burden of dietary restriction. Intermittent fasting reduces body fat storage and increases fat mobilization, oxidation, and ketone body production, resulting in weight loss. A study comparing intermittent fasting with low-energy diets found that, although body weight reductions were similar after three months of follow-up, the reduction in fat mass was greater in the intermittent fasting group.

The term "Mediterranean diet" reflects the food combinations typical of Mediterranean populations such as Greeks, Southern Italians, and Spaniards in the early 1960s. Lower rates of cardiovascular disease (CVD) and chronic diseases associated with aging in these populations led to its popularization. Since November 2010, the Mediterranean diet has been included on the list of the Intangible Cultural Heritage of Humanity by UNESCO, as it represents a heritage closely linked to cultures and lifestyles passed down through centuries and is the result of the complex socioeconomic development of Mediterranean populations.

Eating behavior changes from birth onward, depending on many factors. Eating, which is essential for life, can, in some cases, develop into a psychiatric disorder, or differences from normal eating behaviors can occur. Eating is not an automatic process, especially for young people. It is significantly influenced by the cultural, social, and psychological pressures individuals feel. In recent years, various theories have been developed to assess behaviors that can impair eating motivation, adequate food intake, and body weight control. "Emotional eating" refers to eating to cope with negative emotions and relieve stress by ignoring satiety signals without internal physiological hunger signals. "External eating" refers to eating in response to stimuli related to food consumption, regardless of hunger and satiety signals. "Restrictive eating" reflects the degree to which one deliberately restricts food intake.

Today, the prevalence of non-communicable diseases is increasing, and obesity is among the risk factors for these diseases. While many methods are used in the treatment of obesity, the role of medical nutrition therapy is crucial. Various methods are used in medical nutrition therapy for obesity. These methods include the calorie-restricted Mediterranean diet, the time-restricted eating model (a type of intermittent fasting), and standard dietary intervention. This study will evaluate the effects of these dietary models on individuals' body composition, dietary intake, and eating behaviors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 49 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being between 20-49 years old
  • •Having a BMI value between 25 kg/m2- 35 kg/m2
  • •Not having conditions that impair reality assessment ability and cognitive functions, preventing interviews or filling out scales
  • •Being literate
  • •Having a blood test done by a primary care physician within the last seven days
  • •Agreeing to participate in the study and signing the informed consent form

排除标准

  • •Pregnant and breastfeeding women,
  • •Those who could not attend one or more interview sessions,
  • •Women who have entered menopause,
  • •Individuals who want to apply another diet model,
  • •Individuals who have a pacemaker or defibrillator implanted due to the theoretical possibility of interference with device activity due to the current field caused by impedance measurements,
  • •Those who have any chronic disease and are on a diet,
  • •Those who regularly use medications that affect metabolism,
  • •Those who use insulin and oral antidiabetic medications,
  • •Those who have allergies or intolerances to any food components of the Mediterranean diet (walnuts, hazelnuts, peanuts, almonds, etc.),
  • •Those who use vitamin/mineral supplements,
  • •Those who have a psychiatric disease diagnosed by a physician.
  • •In order to understand the effectiveness of the diet, individuals will be asked to maintain their physical activity levels. Therefore, individuals who want to increase their physical activity levels in addition to the applied diet will not be included in the study.

研究组 & 干预措施

Mediterranean diet

Active Comparator

Mediterranean diet

干预措施: Mediterranean diet (Other)

standard diet and time-restricted feeding

Active Comparator

standard diet and time-restricted feeding

干预措施: standard diet and time-restricted feeding (Other)

control group

Active Comparator

standard diet

干预措施: Standard diet (Other)

结局指标

主要结局

Diet Satisfaction Scale

时间窗: 12 weeks

The validity and reliability study of the scale, originally named "Diet Satisfaction Scale", developed by Jospe and his colleagues in 2020, was conducted by Eskici and his colleagues in 2021 (Jospe et al 2020, Eskici and Yılmaz 2021). The items of the scale, which is used to evaluate issues such as hunger, desire to prepare food, enjoyment of the diet, following the diet at home and away from home, contribution to physical health, food variety, budget suitability and continuity, which affect the satisfaction of the clients with any diet, include 9-item five-point Likert-type (1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree) answer options. Only item 1 is scored in reverse (1=5, 2=4, 3=3, 4=2 and 5=1). The maximum score that can be obtained from the scale is 45. A high score indicates that diet satisfaction increases.

Three Factor Eating Questionnaire (TFEQ-21)

时间窗: 12 weeks

In order to determine the eating behavior of the individuals participating in the study, the 21-item Three-Factor Eating Scale, which was validated for Turkish culture by Karakuş et al. in 2016, will be used. All of the items are four-point Likert-type and the answers are as follows; 1= Definitely false, 2= Mostly false, 3= Mostly true and 4= Definitely true. This scale measures eating behavior with three sub-dimensions: cognitive restraint (CRI), uncontrolled eating (URI) and emotional eating (EI). Items 1, 5, 11, 17, 18, and 21 measure CRI and evaluate the tendency to control food intake to maintain body weight and body shape. Items 3, 6, 8, 9, 12, 13, 15, 19, and 20 measure CRI and evaluate the tendency to lose control over eating when hungry and exposed to an external stimulus. EI; Items 2, 4, 7, 10, 14 and 16 measure and evaluate the relationship between a negative mood such as loneliness, demoralization or anxiety and overeating. It is recommended to use the converted scale scor

Diet Satisfaction Scale

时间窗: 12 weeks

The validity and reliability study of the scale, originally named "Diet Satisfaction Scale", developed by Jospe and his colleagues in 2020, was conducted by Eskici and his colleagues in 2021 (Jospe et al 2020, Eskici and Yılmaz 2021). The items of the scale, which is used to evaluate issues such as hunger, desire to prepare food, enjoyment of the diet, following the diet at home and away from home, contribution to physical health, food variety, budget suitability and continuity, which affect the satisfaction of the clients with any diet, include 9-item five-point Likert-type (1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree) answer options. Only item 1 is scored in reverse (1=5, 2=4, 3=3, 4=2 and 5=1). The maximum score that can be obtained from the scale is 45. A high score indicates that diet satisfaction increases.

Three Factor Eating Questionnaire (TFEQ-21)

时间窗: 12 weeks

In order to determine the eating behavior of the individuals participating in the study, the 21-item Three-Factor Eating Scale, which was validated for Turkish culture by Karakuş et al. in 2016, will be used. All of the items are four-point Likert-type and the answers are as follows; 1= Definitely false, 2= Mostly false, 3= Mostly true and 4= Definitely true. This scale measures eating behavior with three sub-dimensions: cognitive restraint (CRI), uncontrolled eating (URI) and emotional eating (EI). Items 1, 5, 11, 17, 18, and 21 measure CRI and evaluate the tendency to control food intake to maintain body weight and body shape. Items 3, 6, 8, 9, 12, 13, 15, 19, and 20 measure CRI and evaluate the tendency to lose control over eating when hungry and exposed to an external stimulus. EI; Items 2, 4, 7, 10, 14 and 16 measure and evaluate the relationship between a negative mood such as loneliness, demoralization or anxiety and overeating. It is recommended to use the converted scale scor

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

SUHİDE BİLGE HORZUM

dietician

Selcuk University

研究点 (1)

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