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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05652972
Acronym
KETO-MINOX
Enrollment
80
Registered
2022-12-15
Start date
2023-02-01
Completion date
2026-02-28
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

diet, nutrition, ketogenic diet, inflammation, oxidative stress, overweight

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.

Interventions

OTHERKetogenic diet

1700 kcal ketogenic diet (fat: protein: carbohydrate ratio of 70:20:10)

OTHERControl diet

1700 kcal standard diet (fat: protein: carbohydrate ratio of 20:30:50)

Sponsors

University of Warmia and Mazury
CollaboratorOTHER
Polish Academy of Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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)12 monthsAnalysis using Bio-Plex Pro™ Human Cytokine 17-plex Assay in serum.
Oxidative stress markers12 monthsanalysis of malondialdehyde, superoxide dismutase, 8-isoprostane and 8-hydroxydeoxyguanosine (8-OHdG) using commercial ELISA kits in serum.

Secondary

MeasureTime frameDescription
Free amino acids12 monthsAnalysis of free amino acids in serum using gas chromatography-mass spectrometry, expressed in nmol/mL
Fat-soluble vitamins12 monthsFat-soluble vitamins in serum using commercial ELISA kits (vitamin D) and high-performance liquid chromatography (vitamin A,E & K)
Body weight and composition12 monthsBody weight in kg and composition in % will be measured using Body Composition Analyser
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 monthsAnalyses will be performed using Bio-Plex Assays
Metabolites in breath12 monthsVolatile organic compounds in breath will be measured using dwo dimensional chromatography with time of flight mass spectrometry (GCxGC-ToFMS)
Waist circumference12 monthsThe waist circumference in cm will be measured using a standard measurement tape.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026