Effect of KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight

Overweight and Obesity Clinical Trial

— KETO-MINOX  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05652972
• Other study ID #: 2021/41/B/NZ9/01278
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2023
• Source: Polish Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: February 28, 2026
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Obesity
• Overweight
• Overweight and Obesity

Intervention

Other:
• Ketogenic diet
1700 kcal ketogenic diet (fat: protein: carbohydrate ratio of 70:20:10)
• Control diet
1700 kcal standard diet (fat: protein: carbohydrate ratio of 20:30:50)

Locations

Country	Name	City	State
Poland	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

Sponsors (2)

Lead Sponsor	Collaborator
Polish Academy of Sciences	University of Warmia and Mazury

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	Oxidative stress markers	analysis of malondialdehyde, superoxide dismutase, 8-isoprostane and 8-hydroxydeoxyguanosine (8-OHdG) using commercial ELISA kits in serum.	12 months
Secondary	Body weight and composition	Body weight in kg and composition in % will be measured using Body Composition Analyser	12 months
Secondary	Waist circumference	The waist circumference in cm will be measured using a standard measurement tape.	12 months
Secondary	Free amino acids	Analysis of free amino acids in serum using gas chromatography-mass spectrometry, expressed in nmol/mL	12 months
Secondary	Fat-soluble vitamins	Fat-soluble vitamins in serum using commercial ELISA kits (vitamin D) and high-performance liquid chromatography (vitamin A,E & K)	12 months
Secondary	Metabolites in breath	Volatile organic compounds in breath will be measured using dwo dimensional chromatography with time of flight mass spectrometry (GCxGC-ToFMS)	12 months
Secondary	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	12 months