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

NCT05652972 | Active Not Recruiting

• 1 other identifier: 2021/41/B/NZ9/01278
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity

Keywords

diet; nutrition; ketogenic diet; inflammation; oxidative stress; overweight

Outcome Measures

Primary Outcomes (2)

• Inflammatory markers (G-CSF, GM-CSF, INF-gamma, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, MCP-1, MIP-1b, TNF-a)

  Analysis using Bio-Plex Pro™ Human Cytokine 17-plex Assay in serum.

  12 months

• Oxidative stress markers

  analysis of malondialdehyde, superoxide dismutase, 8-isoprostane and 8-hydroxydeoxyguanosine (8-OHdG) using commercial ELISA kits in serum.

  12 months

Secondary Outcomes (6)

• Body weight and composition

  12 months

• Waist circumference

  12 months

• Free amino acids

  12 months

• Fat-soluble vitamins

  12 months

• Metabolites in breath

  12 months

Study Arms (2)

Ketogenic diet

EXPERIMENTAL

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

Other: Ketogenic diet

Control diet

ACTIVE COMPARATOR

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

Other: Control diet

Interventions

Ketogenic diet OTHER

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

Ketogenic diet

Control diet OTHER

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

Control diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women
• age 18-45
• overweight (BMI 27 - 35)
• motivation to lose weight and participate in the nutritional intervention trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Academy of Sciences: lead
• University of Warmia and Mazury: collaborator

Study Sites (2)

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

Olsztyn, 10-082, Poland

Location

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

Olsztyn, 10-748, Poland

Location

Related Publications (1)

• 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.

  PMID: 37155645 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Inflammation

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Natalia Drabińska, PhD

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

  PRINCIPAL INVESTIGATOR

• Jerzy Romaszko, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 15, 2022
• Study Start: February 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: February 28, 2026
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

PL (2)