RecruitingNot Applicable

Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers

Poland200 participantsStarted 2024-09-02

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

β-hydroxybutyrate

Timeframe: 12 weeks

Insulin

Timeframe: 12 weeks

Glucose

Timeframe: 12 weeks

Omega index

Timeframe: 12 weeks

HDL cholesterol

Timeframe: 12 weeks

LDL cholesterol

Timeframe: 12 weeks

Triacylglycerol

Timeframe: 12 weeks

Grelin

Timeframe: 12 weeks

Trial details

NCT IDNCT07672691

SponsorThe Jerzy Kukuczka Academy of Physical Education in Katowice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-03

Contact for this trial

Małgorzata Magdalena Michalczyk, Assistante professor

+48535016532 m.michalczyk@awf.katowice.pl

View on ClinicalTrials.gov More Nutrition trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.