Clinical trial NCT05652972: Effect of KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight
Official title: KETO-MINOX: The Effect of Isocaloric, Energy-restrictive, KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: diet
nutrition
ketogenic diet
inflammation
oxidative stress
overweight
Lead sponsor: Polish Academy of Sciences
Sponsor class: OTHER
Collaborators: name: University of Warmia and Mazury
First posted: 2022-12-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: 12 months
measure: Oxidative stress markers
timeFrame: 12 months
Secondary outcomes:
measure: Body weight and composition
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
measure: Free amino acids
timeFrame: 12 months
measure: Fat-soluble vitamins
timeFrame: 12 months
measure: Metabolites in breath
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
Other outcomes:
Locations:
city: Olsztyn
country: Poland
facility: Department of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury
city: Olsztyn
country: Poland
facility: Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
Study officials:
affiliation: Institute of Animal Reproduction and Food Reseach, Polish Academy of Sciences in Olsztyn
name: Natalia Drabińska, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deaprtment of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury
name: Jerzy Romaszko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: