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临床试验/NCT05652972
NCT05652972进行中(未招募)不适用

KETO-MINOX: The Effect of Isocaloric, Energy-restrictive, KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight and Obesity

Polish Academy of Sciences4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
4
主要终点
Oxidative stress markers

研究概览

简要总结

In recent times, the prevalence of obesity increases, reaching an epidemic scale. Elevated body weight is a risk factor in the development of several diseases such as diabetes, hypertension and cancer. Therefore, obesity management solutions, such as diet therapy are needed. The key issue is to choose the most appropriate diet to obtain an efficient outcome in losing weight, without experiencing adverse effects and a decrease in general health. A ketogenic diet, an auxiliary therapy for epilepsy, is recently one of the options commonly used for losing weight by overweight individuals, tempted by the commercials and internet influencers. However, there is limited knowledge about the effect of this diet on human health. To date, the majority of studies were conducted with a very-low-calorie regime applied before the bariatric surgeries, which itself may affect the loss of body weight, and in most studies, the control diets were missing. Taking into consideration that a ketogenic diet is an extremely eliminating diet, there is a risk of nutritional deficiencies after following it. Therefore, there is a strong need for more in-depth and comprehensive elucidation of the safety and physiological effects of the ketogenic diet used for the weight loss in overweight and obese individuals.

This Project aims to evaluate the effectiveness of the eight-week, isocaloric, energy-restricted, ketogenic diet as a weight management solution in women with overweight and obesity compared to the standard, balanced diet with the same calorie content.

详细描述

In recent times, the prevalence of obesity increases, reaching an epidemic scale. A new factor supporting a weight gain is a current coronaviros (COVID-19) pandemic, associated with reduced physical activity, high stress and overeating, which resulted in 2-5 kg weight gain in 20 % of the American population within a few months 1. Elevated body weight is a risk factor in developing several diseases such as diabetes, hypertension and cancer. Therefore, obesity management solutions, such as diet therapy, are needed. The critical issue is to choose the most appropriate diet to obtain an efficient outcome in losing weight without experiencing adverse effects and a decrease in general health. A ketogenic diet, an auxiliary therapy for epilepsy, is recently one of the options commonly used for losing weight by individuals with overweight, tempted by the commercials and internet influencers. However, there is limited knowledge about the effect of this diet on human health. To date, the majority of studies were conducted with a very low-calorie regime applied before the bariatric surgeries, which itself may affect the loss of body weight. In most studies, the control diets were missing. Considering that a ketogenic diet is an extremely eliminating diet, there is a risk of nutritional deficiencies after following it. Therefore, there is a strong need for more in-depth and comprehensive elucidation of the safety and physiological effects of the energy-restricted ketogenic diet used for weight loss in individuals with overweight and obese.

This Project aims to evaluate the effectiveness of the eight-week, isocaloric, energy-restricted, ketogenic diet as a weight management solution in women with overweight and obesity compared to the standard, balanced diet with the same calorie content.

研究设计

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

入排标准

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

入选标准

  • age 18-45
  • overweight (BMI 27 - 35)
  • motivation to lose weight and participate in the nutritional intervention trial

排除标准

  • overweight/obesity secondary to genetic syndromes
  • endocrine diseases, acute systemic disease, autoimmune disorders
  • pregnancy
  • breastfeeding
  • type 1 and 2 diabetes
  • any other chronic diseases requiring pharmacotherapy (including topical steroids in allergy disorders
  • supplement or medication use influencing appetite, weight or metabolism)
  • participation in other clinical trials
  • severe obesity (BMI > 35)
  • > 3 kg weight loss 12 weeks before the initial test day
  • extreme changes in exercise intensity 4 weeks prior
  • any diagnosed psychiatric disorders

结局指标

主要结局

Oxidative stress markers

时间窗: 12 months

analysis of malondialdehyde, superoxide dismutase, 8-isoprostane and 8-hydroxydeoxyguanosine (8-OHdG) using commercial ELISA kits in serum.

Inflammatory markers (G-CSF, GM-CSF, INF-gamma, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, MCP-1, MIP-1b, TNF-a)

时间窗: 12 months

Analysis using Bio-Plex Pro™ Human Cytokine 17-plex Assay in serum.

次要结局

  • Metabolites in breath(12 months)
  • Obesity-related markers (C-peptide, ghrelin, gastric inhibitory peptide (GIP), glucagon-like peptide 1 (GLP-1), glucagon, insulin, leptin, plasminogen activation inhibitor-1 (PAI-1), resistin and visfatin, adipsin and adiponectin)(12 months)
  • Waist circumference(12 months)
  • Body weight and composition(12 months)
  • Free amino acids(12 months)
  • Fat-soluble vitamins(12 months)

研究者

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

Natalia Drabińska

Principal Investigator

Polish Academy of Sciences

研究点 (4)

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