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Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers

RecruitingNAAges 18 Years - 60 YearsAllThe Jerzy Kukuczka Academy of Physical Education …
NCT07672691 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This 12-week randomized controlled trial will investigate the effects of dietary patterns with different macronutrient compositions on gut microbiota, intestinal inflammation, gene expression, and metabolic health in healthy adults. Participants will be randomly assigned to one of three dietary interventions: a ketogenic diet (KD), a vegetarian diet (VD), or a control diet (CD) reflecting their habitual mixed dietary pattern. Adherence to the assigned diet will be monitored through dietary records and regular nutritional counseling. The study will evaluate changes in gut microbiota composition, inflammatory biomarkers, transcriptomic profiles, and blood biochemical parameters associated with lipid and glucose metabolism. Blood and stool samples will be collected at predefined time points throughout the intervention, while participants in the KD group will additionally undergo ketone mo

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📋 Eligibility rules (as published)
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
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What it tests

  • Ketogenic Diet (KD)
  • Vegetarian Diet (VD)
  • Control Diet (CD)
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Where

2 sites
Jaggielonian University
Krakow, Poland
Pomeranian Medical University
Szczecin, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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