Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers

Condition(s) studied

Investigational drug(s) / intervention(s)

Ketogenic Diet (KD): Participants in the Ketogenic Diet Group (KD) will follow a strict ketogenic diet for 12 weeks. The ketogenic diet is characterized by: Fat intake: Approximately 70-80% of total daily energy Carbohydrate intake: Approximately 5-10% of total daily energy (typically \<50 g carbohydrates per day) Moderate protein intake: Approximately 15-20% of total daily energy Dietary Guidelines: Allowed foods: Fatty meats, fish, eggs, full-fat dairy products, butter, oils (olive oil, coconut oil, avocado oil), nuts, seeds, low-carbohydrate vegetables (e.g., leafy greens, broccoli, cauliflower), avocados Restricted foods: All grains (bread, pasta, rice, cereals), high-carbohydrate fruits (bananas, apples, oranges), starchy vegetables (potatoes, corn), legumes, sugar-sweetened foods and beverages, most processed foods Blood ketone levels will be measured once weekly by participants (morning, before breakfast) using a ketone meter (Optimum Xido) Duration: 12 weeks

Vegetarian Diet (VD): Participants in the Vegetarin Diet Group (VD) will follow a plant-based vegetarian diet for 12 weeks. The vegetarin diet excludes all animal products and is characterized by: Macronutrient composition: Balanced intake of carbohydrates, proteins, and fats from plant sources Primary food sources: Vegetables, fruits, legumes (beans, lentils, peas), nuts, seeds, whole grains, plant-based oils Dietary Guidelines: Allowed foods: All vegetables, fruits, legumes, nuts, seeds, whole grains (rice, quinoa, oats, wheat), plant-based milks, tofu, tempeh, plant-based oils, avocados Restricted foods: All animal products including meat, poultry, fish, eggs, dairy products, honey, and any food containing animal-derived ingredients Dietary adherence will be monitored through regular food diaries and nutritional counseling sessions Participants will receive guidance on adequate protein intake, vitamin B12, iron, calcium, and omega-3 fatty acid supplementation if needed Duration: 12 weeks

Control Diet (CD): Participants in the Control Diet Group (CD) will serve as the control group and will continue their current habitual mixed diet without specific dietary modifications for 12 weeks. Diet type: Habitual mixed diet (includes both plant and animal products) Macronutrient composition: No modifications; participants maintain their usual dietary intake No dietary restrictions or instructions: Participants are not instructed to change their eating patterns Monitoring: Dietary intake will be documented through regular food diaries Participants will attend visits with a dietitian at 4, 8, and 12 weeks for monitoring purposes only (no dietary changes instructed) Duration: 12 weeks

Study summary

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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

Primary outcome measure(s)

• β-hydroxybutyrate — 12 weeks
  mmol/L
• Insulin — 12 weeks
  IU/mL
• Glucose — 12 weeks
  mg/dL
• Omega index — 12 weeks
• HDL cholesterol — 12 weeks
  mg/dL
• LDL cholesterol — 12 weeks
  mg/dL
• Triacylglycerol — 12 weeks
  mg/dL
• Grelin — 12 weeks
  ng/mL
• cholecystokinin — 12 weeks
  pg/mL
• glucagon-like peptide-1 — 12 weeks
  pg/mL
• leptin — 12 weeks
  ng/mL
• peptide YY — 12 weeks
  pg/mL
• gut microbiome — 12 weeks
  CFU/g
• Transcriptomic — 12 weeks
  log 2fold change
• Gene Polymorphism — 12 weeks
  allel variance
• Total cholesterol — 12 weeks
  mg/dL
• HbA1c — 12 weeks
• Testosterone — 12 weeks
  nmol/L
• Cortisol — 12 weeks
  μg/dL

Trial sites (2)

More The Jerzy Kukuczka Academy of Physical Education in Katowice trials in Poland

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