Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05652972 |
| Other study ID # |
2021/41/B/NZ9/01278 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
