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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
80
1700 kcal ketogenic diet (fat: protein: carbohydrate ratio of 70:20:10)
1700 kcal standard diet (fat: protein: carbohydrate ratio of 20:30:50)
Department of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury
Olsztyn, Poland
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
Olsztyn, Poland
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)
Analysis using Bio-Plex Pro™ Human Cytokine 17-plex Assay in serum.
Time frame: 12 months
Oxidative stress markers
analysis of malondialdehyde, superoxide dismutase, 8-isoprostane and 8-hydroxydeoxyguanosine (8-OHdG) using commercial ELISA kits in serum.
Time frame: 12 months
Body weight and composition
Body weight in kg and composition in % will be measured using Body Composition Analyser
Time frame: 12 months
Waist circumference
The waist circumference in cm will be measured using a standard measurement tape.
Time frame: 12 months
Free amino acids
Analysis of free amino acids in serum using gas chromatography-mass spectrometry, expressed in nmol/mL
Time frame: 12 months
Fat-soluble vitamins
Fat-soluble vitamins in serum using commercial ELISA kits (vitamin D) and high-performance liquid chromatography (vitamin A,E \& K)
Time frame: 12 months
Metabolites in breath
Volatile organic compounds in breath will be measured using dwo dimensional chromatography with time of flight mass spectrometry (GCxGC-ToFMS)
Time frame: 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)
Analyses will be performed using Bio-Plex Assays
Time frame: 12 months
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