Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe Jerzy Kukuczka Academy of Physical Education in Katowice

About this trial

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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

Qualifiers

None

Disqualifiers

Use of medications regulating **glucose levels** (e.g., metformin) or **blood lipids** (e.g., **statins**)

**Hypertension** or pharmacological treatment for hypertension

Gastric and duodenal ulcers

**Irritable bowel syndrome (IBS)**

Trial design

Treatments tested in this trial

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

Treatment groups

200 Participants
are divided into 3 treatment groups

Sponsors and collaborators

The Jerzy Kukuczka Academy of Physical Education in Katowice

Lead sponsor

Jagiellonian University

Collaborator

Pomeranian Medical University Szczecin

Collaborator