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

NCT ID: NCT05652972

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-02-28

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ketogenic diet

40 women which will follow the ketogenic diet with 1700 kcal daily for 8 weeks

Group Type: EXPERIMENTAL

Ketogenic diet

Intervention Type: OTHER

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

Control diet

40 women which will follow the standard diet with 1700 kcal daily for 8 weeks

Group Type: ACTIVE_COMPARATOR

Control diet

Intervention Type: OTHER

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

Interventions

Ketogenic diet

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

Intervention Type: OTHER

Control diet

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Warmia and Mazury

OTHER

Sponsor Role: collaborator

Polish Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Natalia Drabińska

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natalia Drabińska, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Animal Reproduction and Food Reseach, Polish Academy of Sciences in Olsztyn

Jerzy Romaszko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Deaprtment of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury

Locations

Department of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury

Olsztyn, , Poland

Institute of Animal Reproduction and Food Research, Polish Academy of Sciences

Olsztyn, , Poland

Countries

Poland

References

Drabinska N, Romaszko J, White P. The effect of isocaloric, energy-restrictive, KETOgenic diet on metabolism, inflammation, nutrition deficiencies and oxidative stress in women with overweight and obesity (KETO-MINOX): Study protocol. PLoS One. 2023 May 8;18(5):e0285283. doi: 10.1371/journal.pone.0285283. eCollection 2023.

Reference Type: DERIVED

PMID: 37155645 (View on PubMed)

Other Identifiers

2021/41/B/NZ9/01278

Identifier Type: -

Identifier Source: org_study_id