Effect of KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight (KETO-MINOX)

KETO-MINOX: The Effect of Isocaloric, Energy-restrictive, KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight and Obesity

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Ketogenic diet; Other: Control diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalia Drabińska, PhD; Phone Number: +48 89 523 46 41; Email: n.drabinska@pan.olsztyn.pl

Study Locations

• Poland
  • Olsztyn, Poland, 10-082
    • Department of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury
    • Contact: Jerzy Romaszko, MD, PhD; Phone Number: +48 89 524 61 65; Email: jerzy.romaszko@uwm.edu.pl
    • Sub-Investigator: Jerzy Romaszko, MD, PhD
  • Olsztyn, Poland, 10-748
    • Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
    • Contact: Natalia Drabińska, PhD; Phone Number: +48 89 523 46 41; Email: n.drabinska@pan.olsztyn.pl
    • Principal Investigator: Natalia Drabińska, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketogenic diet; 40 women which will follow the ketogenic diet with 1700 kcal daily for 8 weeks	Other: Ketogenic diet; 1700 kcal ketogenic diet (fat: protein: carbohydrate ratio of 70:20:10)
Active Comparator: Control diet; 40 women which will follow the standard diet with 1700 kcal daily for 8 weeks	Other: Control diet; 1700 kcal standard diet (fat: protein: carbohydrate ratio of 20:30:50)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight and composition	Body weight in kg and composition in % will be measured using Body Composition Analyser	12 months
Waist circumference	The waist circumference in cm will be measured using a standard measurement tape.	12 months
Free amino acids	Analysis of free amino acids in serum using gas chromatography-mass spectrometry, expressed in nmol/mL	12 months
Fat-soluble vitamins	Fat-soluble vitamins in serum using commercial ELISA kits (vitamin D) and high-performance liquid chromatography (vitamin A,E & K)	12 months
Metabolites in breath	Volatile organic compounds in breath will be measured using dwo dimensional chromatography with time of flight mass spectrometry (GCxGC-ToFMS)	12 months
Obesity-related markers (C-peptide, ghrelin, gastric inhibitory peptide (GIP), glucagon-like peptide 1 (GLP-1), glucagon, insulin, leptin, plasminogen activation inhibitor-1 (PAI-1), resistin and visfatin, adipsin and adiponectin)	Analyses will be performed using Bio-Plex Assays	12 months

Collaborators and Investigators

• Sponsor: Polish Academy of Sciences
• Collaborators: University of Warmia and Mazury
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): February 28, 2026

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: overweight; nutrition; inflammation; ketogenic diet; diet; oxidative stress
• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Body Weight; Obesity; Inflammation; Overweight
• Other Study ID Numbers: 2021/41/B/NZ9/01278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

During the project only new data will be acquired and/or generated. No existing data re-usage is planned. Similar data do not exist yet, thus the planned project will be the only source/origin of them.

In the project the following data will be generated: numerical data, texts and graphical data (chromatography).

During the the project, two types of data will be generated to further processing:

1. automatic measurement data resulting from the equipment, obtained using the validated methodologies and calibrated equipments with the predefined replicates.
2. non-automatic measurement data resulting from carried out experiments - data documented manually and then entered into a spreadsheets and obtained after the statistical evaluation.

All data will be successfully published in prestigious journals with high Impact Factor. Thus, they will be evaluated by the expert reviewers in the process of revision.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No