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

NCT05652972 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

  • Overweight and Obesity

Interventions

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)

Sponsors & Collaborators

  • University of Warmia and Mazury

    collaborator OTHER

  • Polish Academy of Sciences

    lead OTHER

Principal Investigators

  • Natalia Drabińska, PhD · Institute of Animal Reproduction and Food Reseach, Polish Academy of Sciences in Olsztyn

  • Jerzy Romaszko, MD, PhD · Deaprtment of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-05-30
Completion
2026-02-28

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652972 on ClinicalTrials.gov