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临床试验/NCT06621940
NCT06621940已完成不适用

Effect of High Protein Diet on Total Antioxidant Capacity

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月25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
20
试验地点
1
主要终点
Antioxidant capacity after high protein diet

研究概览

简要总结

This study was planned to provide information about the effect of short-term high protein diet (HPD) feeding on early antioxidant response in women. The definition of HPDs cannot be determined exactly. It is defined differently by various scientific authorities. However, protein is targeted to be approximately 30% of total energy in HPD. It has been determined that HPDs increase satiety, thermogenesis, and provide body weight loss and maintenance of loss. In general, there is evidence that HPD provides more body weight loss in a short time compared to low protein diets. It has been emphasized that the effect of high protein diet on weight loss is related to creating satiety, thus decreasing food intake and increasing thermogenesis. However, the physiological, biochemical and molecular events that occur due to HPD feeding have not been fully understood and the results have not been explained. The effects of HPDs have been determined to last from 1 to 6 days to 6 months. The absence of any study in the literature on the short-term and long-term effects of HPD on oxidative events in humans reveals the original value of this study. Therefore, considering that long-term HPD feeding may increase the risk of cardiovascular disease, blood pressure, and blood lipid levels, the effect of short-term HPD feeding on antioxidant capacity will be investigated in order to avoid these side effects. The planned interviews and measurements for this prospective analytical study will be carried out in the Anthropometry laboratory of the Department of Nutrition and Dietetics, Faculty of Health Sciences at Erciyes University, and blood analyses will be carried out in the Betül Ziya Eren Genome and Stem Cell Research Center laboratory and the Erciyes University Gülser and Dr. Mustafa Gündoğdu Comprehensive Service Laboratory. Healthy female individuals will be applied HPD for 10 days and a normal diet for 10 days as a control. As a result of the applied diets, the expected results of the study are that HPD will cause a decrease in body weight and an increase in lean body mass, even for a short time, and that HPD will have an effect on diet-induced inflammation, cause oxidative stress, affect antioxidant capacity and cause changes in the measured parameters.

详细描述

Today, most individuals try various nutritional models/diets to reduce body weight. One of the most popular of these diets is the diets that reduce carbohydrate intake. Western societies generally avoid high carbohydrates and fat intake. For this reason, interest in high protein intake in diets is increasing day by day. Although there is no general consensus on what a high-protein diet is, the high protein diet (HPD) applied for weight loss studies is diets that contain approximately 30% of the energy provided by protein. The World Health Organization (WHO) has defined obesity as an endemic public problem and stated that its prevalence is increasing. With the increase in obesity, individuals try various dietary modifications to achieve weight loss. These include diets with a more regular macro and micronutrient pattern, such as the Mediterranean Diet and the DASH diet, and diets that may cause deficiencies in terms of macro and micronutrients, such as Atkins, South Beach, Zone, and Stillman, which contain high protein. The most important reasons why high-protein diets attract attention are that they cause rapid weight loss and provide satiety. This positive effect of HPDs on weight loss has attracted the attention of dietitians and caused them to increase the protein ratio in diets. Scientific authorities against popular diets; what is really known about popular diets, the scientific nature of the information, whether it is effective in maintaining body weight, if it is effective, its effect on body composition, micronutrient level, metabolic indicators, hunger-satiety, psychological state, chronic disease risk, its effect on leptin and insulin levels, which provide hormone regulation in long-term energy intake and expenditure.

It is known that HPDs provide more effective results in body weight loss compared to low protein diets. It is suggested that this effect occurs as a result of increased thermogenesis, increased satiety and suppressed appetite, and reduced glycemic index and glycemic load due to the replacement of refined carbohydrates with proteins. In addition to this positive effect on weight loss, there are possible short- and long-term side effects of HPD nutrition. Known complications of long-term HPD nutrition include increased cardiovascular disease risk, blood pressure, blood lipids, and kidney dysfunction. Cardiovascular problems in particular are a source of concern because they will counteract the short-term positive effect of HPD on weight loss and increase the burden of cardiovascular disease in the long term. Studies generally focus on HPD and weight loss; there is limited data on the relationship between HPD nutrition and metabolic dysfunction such as endothelial dysfunction, inflammatory markers, antioxidant status, and other chronic diseases. The physiological, biochemical, and molecular events that occur due to high protein diet nutrition have not been fully understood and their results have not been explained.

High protein diets (especially low carbohydrate diets) are thought to have negative effects because they cause a decrease in fruit and vegetable consumption. In those who eat a HPD, especially inadequate vitamin A, C and E in their diets, this will have a negative effect on antioxidant systems and will pave the way for the development of many chronic and metabolic diseases in the long term. Despite the positive effects of HPD applied as a weight loss diet in the short term, it is thought that the oxidative stress and inflammation it will create in the long term will cause an increase in chronic and metabolic diseases as well as comorbidities. This increase in the disease burden will increase health expenditures both individually and socially.

Therefore, this study was planned to provide information about the effect of short-term HPD feeding on early antioxidant response in adult, healthy, normal body mass index female individuals. As a result of the study, it is thought that short-term HPD feeding will cause an increase in oxidative stress, a decrease in antioxidant capacity and an increase in inflammatory biomarkers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None (Participant)

盲法说明

The study was classified as open-label because all participants received the same fixed intervention sequence. However, laboratory personnel assessing biochemical, oxidative, antioxidant, and inflammatory outcomes were blinded to the dietary intervention periods. Blood samples were coded before analysis and decoded only after all assays had been completed.

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Being between 19-45 years of age,
  • •Not changing physical activity throughout the study,
  • •Having a BMI of 18.5-24.9 kg/m2,
  • •Being healthy

排除标准

  • •Having a BMI of <18.5 and ≥25 kg/m2,
  • •Having a chronic disease,
  • •Smoking and drinking alcohol,
  • •Using vitamin-mineral supplements and herbal supplements,
  • •Being pregnant or breastfeeding,
  • •Having entered menopause,
  • •Being on any diet.

研究组 & 干预措施

Fixed-Sequence Dietary Intervention

Experimental

All participants received the same fixed sequence of dietary interventions. Participants first received a high-protein diet for 10 days (40% carbohydrate, 30% protein, and 30% fat), followed by a two-week wash-out period during which they maintained their habitual dietary intake. They subsequently received a normal-protein diet for 10 days (55% carbohydrate, 15% protein, and 30% fat). Participants were instructed not to consume foods or beverages other than those permitted by the study protocol during both intervention periods. The intervention order was not randomized.

干预措施: High Protein Diet (Other)

Fixed-Sequence Dietary Intervention

Experimental

All participants received the same fixed sequence of dietary interventions. Participants first received a high-protein diet for 10 days (40% carbohydrate, 30% protein, and 30% fat), followed by a two-week wash-out period during which they maintained their habitual dietary intake. They subsequently received a normal-protein diet for 10 days (55% carbohydrate, 15% protein, and 30% fat). Participants were instructed not to consume foods or beverages other than those permitted by the study protocol during both intervention periods. The intervention order was not randomized.

干预措施: Normal Protein Diet (Other)

结局指标

主要结局

Antioxidant capacity after high protein diet

时间窗: Day after diet end

After the diet, antioxidant biomarkers \[antioxidant status (TAS), total oxidant status (TOS)\] will be measured in the blood. Lower values represent a worse outcome.

Anthropometric measurements after high protein diet

时间窗: Day after diet end

Anthropometric measurements will be made after the diet. An increase in anthropometric measurements represents a worse result.

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

Aslı Onur Canaydın

Research Assistant

TC Erciyes University

研究点 (1)

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