NCT05652972

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Polish Academy of Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
OTHER	Ketogenic diet	1700 kcal ketogenic diet (fat: protein: carbohydrate ratio of 70:20:10)
OTHER	Control diet	1700 kcal standard diet (fat: protein: carbohydrate ratio of 20:30:50)

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-05-30
• Completion: 2026-02-28
• First posted: 2022-12-15
• Last updated: 2023-05-10

Locations

2 sites across 1 country: Poland