NCT07672691 Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers
| NCT ID | NCT07672691 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Jerzy Kukuczka Academy of Physical Education in Katowice |
| Condition | Nutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2024-09-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-09-02 with a primary completion date of 2024-09-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Małgorzata M Michalczyk, Assistante professor
PRINCIPAL INVESTIGATOR
Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
Frequently Asked Questions
Who can join the NCT07672691 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Nutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07672691 currently recruiting?
Yes, NCT07672691 is actively recruiting participants. Contact the research team at m.michalczyk@awf.katowice.pl for enrollment information.
Where is the NCT07672691 trial being conducted?
This trial is being conducted at Krakow, Poland, Szczecin, Poland.
Who is sponsoring the NCT07672691 clinical trial?
NCT07672691 is sponsored by The Jerzy Kukuczka Academy of Physical Education in Katowice. The principal investigator is Małgorzata M Michalczyk, Assistante professor at Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice. The trial plans to enroll 200 participants.