Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers
Recruiting now · Not applicable
Conditions studied: Nutrition, Ketogenic Diet, Gene Expression, Diet
In brief
Poniżej znajduje się bardziej płynna i mniej powtarzalna wersja tekstu: 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 monitoring to assess dietary compliance. By comparing the ketogenic and vegetarian diets with a standard mixed diet, this study aims to determine their effects on gut health, metabolic function, and systemic inflammation, thereby providing evidence to inform dietary recommendations. Ta wersja eliminuje powtórzenia ("diet", "study", "monitor", "effects"), jest bardziej naturalna stylistycznie i odpowiada standardowi językowemu publikacji w czasopismach z zakresu żywienia i medycyny.
Key facts
- Study ID
- NCT07672691
- Run by
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- People needed
- 200
- Starts
- 2024-09-02
- Expected to finish
- 2028-12-30
- Last updated by the study team
- 2026-07-02
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 is running
- Jaggielonian University — Krakow, Poland (enrolling)
- Pomeranian Medical University — Szczecin, Poland (enrolling)
Full record on ClinicalTrials.gov
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