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NCT05652972
Effect of KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight
Conditions: Overweight and Obesity
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 80
Sponsor: Polish Academy of Sciences
Location: Poland
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.
Eligibility Criteria
Inclusion Criteria:womenage 18-45overweight (BMI 27 - 35)motivation to lose weight and participate in the nutritional intervention trialExclusion Criteria:overweight/obesity secondary to genetic syndromesendocrine diseases, acute systemic disease, autoimmune disorderspregnancybreastfeedingtype 1 and 2 diabetesany other chronic diseases requiring pharmacotherapy (including topical steroids in allergy disorderssupplement or medication use influencing appetite, weight or metabolism)participation in other clinical trialssevere obesity (BMI > 35)> 3 kg weight loss 12 weeks before the initial test dayextreme changes in exercise intensity 4 weeks priorany diagnosed psychiatric disorders
Source: ClinicalTrials.gov (NCT05652972). StuddyBuddy aggregates publicly available trial information.