Clinical trial Recruiting at 2 sites Interventional Ages 18 to 60

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.

More Diet, Healthy trials

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment200 (estimated)
SponsorThe Jerzy Kukuczka Academy of Physical Education in Katowice
Academic / other
Drugs / interventionsradiation
Locations2 sites (Krakow and 1 other locations)
StatusRecruiting
StartedSeptember 2, 2024
Main results expectedSeptember 3, 2024
Study endsDecember 30, 2028
Registry record updatedOctober 21, 2026
Trial IDNCT07672691 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.