Diet patterns and gut health: effects of ketogenic, vegetarian, and habitual diets
Official title: Effects of Diets Differing in Macronutrient Composition on Gut Microbiota Composition, Intestinal Inflammation Markers, Gene Expression Profiles, and Blood Biochemical Parameters in Diverse Populations.
Run by The Jerzy Kukuczka Academy of Physical Education in Katowice · NCT07672691 · Data updated 2026-11-12
This 12-week randomized trial tests whether ketogenic, vegetarian, or habitual diets change gut microbiota, inflammation, gene expression, and metabolic markers in healthy adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | The Jerzy Kukuczka Academy of Physical Education in Katowice Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Krakow and 1 other locations) |
| Status | Recruiting |
| Started | September 2, 2024 |
| Main results expected | September 3, 2024 |
| Study ends | December 30, 2028 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07672691 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18-60 with BMI up to 40 kg/m² and a habitual mixed diet.
✕Probably not a fit
Individuals with chronic gastrointestinal disorders, uncontrolled hypertension, or those unable to adhere to dietary restrictions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this 12-week study, healthy adults are randomized to follow a ketogenic diet, a vegetarian diet, or their usual mixed diet. Researchers will monitor adherence with dietary records and counseling, and collect blood and stool samples at baseline, week 4, week 8, and week 12. The study measures include body composition, transcriptomic profiles, cellular metabolism, blood biochemistry, and gut microbiome composition, with ketone levels tracked in the ketogenic group to confirm adherence. The goal is to see how macronutrient composition influences metabolic health, inflammation, and gene expression.
Why it matters
Potential benefit: If successful, the study could clarify how different macronutrient patterns influence metabolism and gut health, potentially guiding personalized nutrition.
How similar studies have gone: Previous studies in dietary patterns and gut microbiome have shown detectable changes with macronutrient shifts, supporting the feasibility of this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: In addition to the physical activity requirements described above, the study will include men and women aged 18-60 years with: BMI not exceeding 40kg/m² Habitual mixed diet prior to study enrollment Normal blood pressure * Exclusion Criteria: Poprawiłem już \*\*Exclusion Criteria\*\* w poprzedniej odpowiedzi - wszystkie te kryteria już tam są wpisane. Oto pełna, ostateczna wersja z wszystkimi wskazanymi kryteriami wyłączenia: \*\*\* \*\*Exclusion Criteria:\*\* * Use of medications regulating \*\*glucose levels\*\* (e.g., metformin) or \*\*blood lipids\*\* (e.g., \*\*statins\*\*) * \*\*Hypertension\*\* or pharmacological treatment for hypertension * Diagnosed \*\*gastrointestinal disorders\*\*, including: * Gastric and duodenal ulcers * \*\*Irritable bowel syndrome (IBS)\*\* * \*\*Ulcerative colitis\*\* * \*\*Celiac disease\*\* * Chronic use of medications such as: * \*\*Mesalazine\*\* * \*\*Corticosteroids\*\* * \*\*Statins\*\* * \*\*Proton pump inhibitors (PPI)\*\* * \*\*Non-steroidal anti-inflammatory drugs (NSAIDs)\*\* * \*\*Anticonceptional medications\*\* * \*\*Any supplements\*\* * \*\*Alcohol consumption\*\* \> 2 times/week with \> 15 g alcohol per occasion (approximately 15 g alcohol = 330 mL beer, 150 mL dry red wine, or 50 mL vodka) * \*\*Smoking cigarettes\*\* * Following a \*\*ketogenic diet\*\* or \*\*vegetarian diet\*\* within \*\*1 month\*\* prior to study enrollment
Where it's running
-
Jaggielonian University
Krakow, Poland Recruiting -
Pomeranian Medical University
Szczecin, Poland Recruiting
Study contacts
- Principal investigator: Małgorzata M Michalczyk, Assistante professor — Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
- Study coordinator: Małgorzata Magdalena Michalczyk, Assistante professor
- Email: m.michalczyk@awf.katowice.pl
- Phone: +48535016532
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.