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临床试验/NCT06886490
NCT06886490已完成不适用

Effects of Plant-based Diets on Body Weight and Selected Metabolic Parameters in Obese Patients: a Randomised Controlled Trial of Five Different Diets

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年10月1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
发起方
入组人数
90
试验地点
1
主要终点
Body weight

研究概览

简要总结

The aim of the study is to determine the optimal plant-based dietary model in terms of weight loss and health that would be both acceptable and environmentally friendly dietary model based on limiting the consumption of meat and animal products. Such findings will lead to new knowledge and allow us to formulate new principles for the nutritional treatment of people suffering from obesity.

详细描述

Obesity is not only one of the most serious health problems in the world, it is also associated with an increased risk of many other diseases. Despite many preventive measures, the number of people suffering from obesity is constantly increasing, also in Poland. One of the integral elements of treatment is a change in lifestyle, including a change in eating habits. In this context, new dietary models are constantly being considered and eagerly adopted by patients. These are not always rational and evidence-based choices. What's more, what we eat is not only important for our health, but also for the planet. Recently, high-fat diets with a significant carbon footprint have gained popularity.

It is therefore worth considering more plant-based dietary models in the treatment of obesity and its associated disorders. Such a change can simultaneously help reduce greenhouse gas emissions and improve environmental quality, as well as benefit our health - both directly and indirectly.

There is a growing body of scientific evidence suggesting that limiting meat consumption may be beneficial to health, leading to weight loss, improvements in selected cardiovascular risk parameters and inflammation. However, many questions remain.

For this reason, more plant-based dietary patterns are worth considering in the treatment of obesity and its accompanying disorders. There is growing scientific evidence that limiting meat consumption promotes good health. It has been shown that the implementation of a vegetarian diet can result in weight loss, as well as help in maintaining optimal weight levels more effectively in the long term. This is extremely important for people suffering from obesity. Adherence to meat-restricted diets is also associated with other health benefits, which include an improved lipid profile and other cardiovascular risk parameters, as well as beneficial effects on inflammation and oxidative stress parameters.

Currently, there are only a few intervention studies available that have investigated the effectiveness of plant-based diets in a population of obese adults who previously have not restricted their meat consumption. Most of the studies concern vegetarians, whose awareness of taking care of their diet and lifestyle is, after all, much higher. To some extent, this may explain such optimistic conclusions from observational studies. It is not the only issue associated with research focused on plant-based diets. In experimental studies, the results of dietary interventions are very often compared with no intervention whatsoever. It would therefore be interesting to verify the effectiveness of a vegan or vegetarian diet against current dietary recommendations or another health-promoting dietary pattern - the Mediterranean diet. After all, vegan or vegetarian diets are elimination diets. Should they be recommended for the treatment of obesity and disorders associated with it? Do body weight, cholesterol and glucose levels decrease faster? What risks do they entail and are they difficult to implement? The investigators only know the answers to some of these questions.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age >18 years (adults able to give informed consent to participate in the study) ≤ 60 years of age
  • •BMI >30 kg/m2 or BMI 25-29.9 kg/m2 with waist circumference in women 88 cm, in men 94cm.

排除标准

  • •age <18 years and >60 years,
  • •severe medical conditions, including alcoholism, major and extensive surgery, chronic kidney and liver disease, history of myocardial infarction, unstable angina pectoris within the last 6 months, history of stroke within the last 6 months, cancer within the last 5 years,
  • •psychiatric condition preventing participation in the study and cooperation with the investigators,
  • •use of enteral or parenteral nutrition,
  • •use of medications that cause significant weight loss (e.g., GLP-1 analogues)
  • •pregnancy or breast feeding,
  • •attempts to change dietary habits, including reduction of caloric intake and elimination of meat and animal products in the past 6 months,
  • •lack of consent to participate in the study.

研究组 & 干预措施

Mediterranean diet

Experimental

This heart-healthy eating plan emphasizes healthy fats, whole grains, fruits, vegetables, beans, nuts and seeds.

干预措施: Mediterranean diet (Other)

Planetary diet

Experimental

Defined in the EAT-Lancet Commission report

干预措施: Planetary diet (Other)

Lactovegetarian diet

Experimental

A variation of vegetarianism that excludes meat, poultry, seafood, and eggs, but includes dairy products.

干预措施: Lactovegetarian diet (Other)

Vegan diet

Experimental

Based on plants (such as vegetables, grains, nuts and fruits) and foods made from plants.

干预措施: Vegan diet (Other)

Control diet

Experimental

Based on the current national dietary recommendations for the Polish population

干预措施: Control diet (Other)

结局指标

主要结局

Body weight

时间窗: After 12 weeks of dietary intervention

Mean incremental difference in body weight (kg) change of 1% consecutively between each of the five groups (corresponding to an effect size of 0.57)

次要结局

  • Glucose level changes(After 12 weeks of intervention.)
  • Waist and hip circumference(After 12 weeks of intervention)
  • Waist-Hip Ratio (WHR)(After 12 weeks of intervention)
  • Body fat mass(After 12 weeks of intervention])
  • Lipids profile(After 12 weeks of intervention)
  • Blood Uric Acid(After 12 weeks of intervention)
  • Serum Micronutrient Levels(After 12 weeks of intervention)
  • Liver Enzymes Activity(After 12 weeks of intervention)
  • Inflammatory Markers(After 12 weeks of intervention)
  • Insulin level changes(After 12 weeks of intervention)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANNA JAGIELSKA

Principal Investigator

Medical University of Warsaw

研究点 (1)

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