Overweight and ObesityKETO-MINOXNCT05652972
Effect of KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight
A study testing Ketogenic diet in people with Overweight and Obesity, run by Polish Academy of Sciences at 2 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Feb 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women
- age 18-45
- overweight (BMI 27 - 35)
- motivation to lose weight and participate in the nutritional intervention trial
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Department of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury
Olsztyn, 10-082
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
Olsztyn, 10-748
About this study
Official title: 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.
Read the 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
- Being tested
- Ketogenic diet, Control diet
- Keywords
- diet, nutrition, ketogenic diet, inflammation, oxidative stress, overweight
- Medical subject headings
- Overweight, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
1700 kcal ketogenic diet (fat: protein: carbohydrate ratio of 70:20:10)
Control dietOther
1700 kcal standard diet (fat: protein: carbohydrate ratio of 20:30:50)
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | 40 women which will follow the ketogenic diet with 1700 kcal daily for 8 weeks Receives: Other: Ketogenic diet |
| Control diet | Active comparator | 40 women which will follow the standard diet with 1700 kcal daily for 8 weeks Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Oxidative stress markers
analysis of malondialdehyde, superoxide dismutase, 8-isoprostane and 8-hydroxydeoxyguanosine (8-OHdG) using commercial ELISA kits in serum.
Measured: 12 months
Secondary outcomes (6)
Body weight and composition
Body weight in kg and composition in % will be measured using Body Composition Analyser
Measured: 12 months
Waist circumference
The waist circumference in cm will be measured using a standard measurement tape.
Measured: 12 months
Free amino acids
Analysis of free amino acids in serum using gas chromatography-mass spectrometry, expressed in nmol/mL
Measured: 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)
Measured: 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)
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Feb 2023
- Primary completion30 May 2024 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warmia and Mazury
- Responsible party
- Principal investigator, Natalia Drabińska, Polish Academy of Sciences
- Investigators
- Natalia Drabińska, PhD, Principal investigator, Institute of Animal Reproduction and Food Reseach, Polish Academy of Sciences in OlsztynJerzy Romaszko, MD, PhD, Principal investigator, Deaprtment of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652972
- Sponsor's protocol ID
- 2021/41/B/NZ9/01278
- Acronym
- KETO-MINOX
- Status last verified
- May 2023
- First submitted
- 29 Nov 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Drabinska-Fois N, Bauer W, Baczek N, Borowicz-Skoneczny S, Romaszko J. Circulating biomarkers of oxidative stress and antioxidant status in women with overweight and obesity following an 8-week energy-restricted ketogenic diet: Results from the randomized KETO-MINOX study. Clin Nutr. 2026 Oct 9;67:106816. doi: 10.1016/j.clnu.2026.106816. Online ahead of print.
PubMed 42887446Drabinska-Fois N, Ogrodowczyk AM, Bauer W, Topolska J, Baczek N, Stenback V, Herzig KH, Borowicz-Skoneczny S, Romaszko J. Immune-modulating effects of energy-restricted ketogenic diet in women with overweight and obesity: KETO-MINOX study. Eur J Nutr. 2026 Mar 7;65(3):83. doi: 10.1007/s00394-026-03935-7.
PubMed 41793518Drabinska 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.
PubMed 37155645
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KETO-MINOX: The Effect of Isocaloric, Energy-restrictive, KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT05652972
- Acronym / sponsor ID
- KETO-MINOX / 2021/41/B/NZ9/01278
- Conditions
- Overweight and Obesity
- Keywords
- diet, nutrition, ketogenic diet, inflammation, oxidative stress, overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Polish Academy of SciencesUniversity, hospital or other
- Collaborators
- University of Warmia and Mazury
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Other: Ketogenic diet40 women which will follow the ketogenic diet with 1700 kcal daily for 8 weeks |
| Control diet | Active comparator | Other: Control diet40 women which will follow the standard diet with 1700 kcal daily for 8 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women
- age 18-45
- overweight (BMI 27 - 35)
- motivation to lose weight and participate in the nutritional intervention trial
Key exclusion criteria (12 listed)
- overweight/obesity secondary to genetic syndromes
- endocrine diseases, acute systemic disease, autoimmune disorders
- pregnancy
- breastfeeding
- type 1 and 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic diet1700 kcal ketogenic diet (fat: protein: carbohydrate ratio of 70:20:10) | Other | Ketogenic diet |
| Control diet1700 kcal standard diet (fat: protein: carbohydrate ratio of 20:30:50) | Other | Control diet |
Primary outcome
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)
Time frame: 12 months
Analysis using Bio-Plex Pro™ Human Cytokine 17-plex Assay in serum.
Oxidative stress markers
Time frame: 12 months
analysis of malondialdehyde, superoxide dismutase, 8-isoprostane and 8-hydroxydeoxyguanosine (8-OHdG) using commercial ELISA kits in serum.
6 secondary outcomes
Body weight and composition
Time frame: 12 months
Waist circumference
Time frame: 12 months
Free amino acids
Time frame: 12 months
Fat-soluble vitamins
Time frame: 12 months
Metabolites in breath
Time frame: 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)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 42887446Drabinska-Fois N, Bauer W, Baczek N, Borowicz-Skoneczny S, Romaszko J. Circulating biomarkers of oxidative stress and antioxidant status in women with overweight and obesity following an 8-week energy-restricted ketogenic diet: Results from the randomized KETO-MINOX study. Clin Nutr. 2026 Oct 9;67:106816. doi: 10.1016/j.clnu.2026.106816. Online ahead of print.
- Derived from this study: PubMed 41793518Drabinska-Fois N, Ogrodowczyk AM, Bauer W, Topolska J, Baczek N, Stenback V, Herzig KH, Borowicz-Skoneczny S, Romaszko J. Immune-modulating effects of energy-restricted ketogenic diet in women with overweight and obesity: KETO-MINOX study. Eur J Nutr. 2026 Mar 7;65(3):83. doi: 10.1007/s00394-026-03935-7.
- Derived from this study: PubMed 37155645Drabinska 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Drabińska, PhD principal investigator
Institute of Animal Reproduction and Food Reseach, Polish Academy of Sciences in Olsztyn
Jerzy Romaszko, MD, PhD principal investigator
Deaprtment of Family Medicine and Infectious Diseases, Faculty of Medical Sciences, University of Warmia and Mazury
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Overweight and Obesity, run by Polish Academy of Sciences at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05652972, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.