Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers (NCT07672691) | Clinical Trial Compass
RecruitingNot Applicable
Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers
Poland200 participantsStarted 2024-09-02
Plain-language summary
This 12-week clinical study will investigate how diets with different macronutrient compositions affect gut microbiota, intestinal inflammation markers, gene expression, and blood biochemical parameters.
Participants will be randomly selected and assigned to three groups:
* KD group: follows a ketogenic diet (high fat, very low carbohydrate, moderate protein)
* VD group: follows a vegetarian diet (plant-based, no animal products)
* CD group: control group maintaining their current mixed diet
Throughout the intervention, participants will provide stool samples for microbiota analysis, blood samples for biochemical and inflammatory marker assessment, and gene expression profiling. Dietary adherence will be monitored through food diaries and regular nutritional counseling.
The study aims to determine how ketogenic and vegan diets compared to a standard mixed diet influence gut health, inflammation, and metabolic parameters. Results will help inform clinical dietary recommendations for gut microbiota modulation and metabolic health improvement.
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
1
β-hydroxybutyrate
Timeframe: 12 weeks
2
Insulin
Timeframe: 12 weeks
3
Glucose
Timeframe: 12 weeks
4
Omega index
Timeframe: 12 weeks
5
HDL cholesterol
Timeframe: 12 weeks
6
LDL cholesterol
Timeframe: 12 weeks
7
Triacylglycerol
Timeframe: 12 weeks
8
Grelin
Timeframe: 12 weeks
9
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