[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644813":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":44,"locations":52,"responsibleParty":87,"collaborators":90,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":30,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":119,"overallStatus":55,"whyStopped":30,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"The Jerzy Kukuczka Academy of Physical Education in Katowice","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketogenic diet","EXPERIMENTAL","Participants in this arm will follow a ketogenic diet characterized by high fat, very low carbohydrate, and moderate protein intake throughout the 12-week intervention period.",[13],"Other: Ketogenic Diet (KD)",{"label":15,"type":10,"description":16,"interventionNames":17},"Vegetarian Diet Group","Participants in this arm will follow a plant-based vegan diet excluding all animal products throughout the 12-week intervention period.",[18],"Other: Vegetarian Diet (VD)",{"label":20,"type":21,"description":22,"interventionNames":23},"Control Diet Group (CD)","PLACEBO_COMPARATOR","Participants in this arm will serve as the control group and will continue their current habitual mixed diet without specific dietary modifications throughout the 12-week study period.",[24],"Other: Control Diet (CD)",[26,31,35],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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:\n\nFat intake: Approximately 70-80% of total daily energy Carbohydrate intake: Approximately 5-10% of total daily energy (typically \\\u003C50 g carbohydrates per day) Moderate protein intake: Approximately 15-20% of total daily energy\n\nDietary Guidelines:\n\nAllowed 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",[9],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"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:\n\nMacronutrient composition: Balanced intake of carbohydrates, proteins, and fats from plant sources\n\nPrimary food sources: Vegetables, fruits, legumes (beans, lentils, peas), nuts, seeds, whole grains, plant-based oils\n\nDietary Guidelines:\n\nAllowed 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\n\nParticipants will receive guidance on adequate protein intake, vitamin B12, iron, calcium, and omega-3 fatty acid supplementation if needed Duration: 12 weeks",[15],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"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.\n\nDiet type: Habitual mixed diet (includes both plant and animal products)\n\nMacronutrient composition: No modifications; participants maintain their usual dietary intake No dietary restrictions or instructions: Participants are not instructed to change their eating patterns\n\nMonitoring:\n\nDietary 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",[20],[40],{"name":41,"affiliation":42,"role":43},"Małgorzata M Michalczyk, Assistante professor","Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"Małgorzata Magdalena Michalczyk, Assistante professor","CONTACT","+48535016532","m.michalczyk@awf.katowice.pl",{"name":46,"role":47,"phone":51,"phoneExt":30,"email":49},"535016532",[53,70],{"facility":54,"status":55,"city":56,"state":30,"zip":30,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Jaggielonian University","RECRUITING","Krakow","Poland","PL",{"type":60,"coordinates":61},"Point",[62,63],19.93658,50.06143,{"lat":63,"lon":62},[66],{"name":67,"role":47,"phone":68,"phoneExt":30,"email":69},"Wojciech Branicki, Profesor","605576336","wojciech.branicki@uj.edu.pl",{"facility":71,"status":55,"city":72,"state":30,"zip":30,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Pomeranian Medical University","Szczecin",{"type":60,"coordinates":74},[75,76],14.55302,53.42894,{"lat":76,"lon":75},[79,83],{"name":80,"role":47,"phone":81,"phoneExt":30,"email":82},"Ewelina Pośpiech, Assistance professor","Pomeranian Medical","ewelina.pospiech@pum.edu.pl",{"name":84,"role":47,"phone":85,"phoneExt":30,"email":86},"Grzegorz Zydek, Phd","504332664","g.zydek@awf.katowice.pl",{"type":43,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Małgorzata Magdalena Michalczyk","assistant professor",[91,93],{"name":92,"class":6},"Jagiellonian University",{"name":94,"class":6},"Pomeranian Medical University Szczecin","100644813","dietary-macronutrients-and-gut-microbiota-inflammation-and-metabolic-markers-100644813",false,"NCT07672691","Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers","Effects of Diets Differing in Macronutrient Composition on Gut Microbiota Composition, Intestinal Inflammation Markers, Gene Expression Profiles, and Blood Biochemical Parameters in Diverse Populations.","DIETMICRO","Inclusion Criteria:\n\nIn addition to the physical activity requirements described above, the study will include men and women aged 18-60 years with:\n\nBMI not exceeding 40kg\u002Fm²\n\nHabitual mixed diet prior to study enrollment\n\nNormal blood pressure\n\n* Exclusion Criteria:\n\nPoprawiłem już \\*\\*Exclusion Criteria\\*\\* w poprzedniej odpowiedzi - wszystkie te kryteria już tam są wpisane. Oto pełna, ostateczna wersja z wszystkimi wskazanymi kryteriami wyłączenia:\n\n\\*\\*\\* \\*\\*Exclusion Criteria:\\*\\*\n\n* Use of medications regulating \\*\\*glucose levels\\*\\* (e.g., metformin) or \\*\\*blood lipids\\*\\* (e.g., \\*\\*statins\\*\\*)\n* \\*\\*Hypertension\\*\\* or pharmacological treatment for hypertension\n* Diagnosed \\*\\*gastrointestinal disorders\\*\\*, including:\n* Gastric and duodenal ulcers\n* \\*\\*Irritable bowel syndrome (IBS)\\*\\*\n* \\*\\*Ulcerative colitis\\*\\*\n* \\*\\*Celiac disease\\*\\*\n* Chronic use of medications such as:\n* \\*\\*Mesalazine\\*\\*\n* \\*\\*Corticosteroids\\*\\*\n* \\*\\*Statins\\*\\*\n* \\*\\*Proton pump inhibitors (PPI)\\*\\*\n* \\*\\*Non-steroidal anti-inflammatory drugs (NSAIDs)\\*\\*\n* \\*\\*Anticonceptional medications\\*\\*\n* \\*\\*Any supplements\\*\\*\n* \\*\\*Alcohol consumption\\*\\* \\> 2 times\u002Fweek with \\> 15 g alcohol per occasion (approximately 15 g alcohol = 330 mL beer, 150 mL dry red wine, or 50 mL vodka)\n* \\*\\*Smoking cigarettes\\*\\*\n* Following a \\*\\*ketogenic diet\\*\\* or \\*\\*vegetarian diet\\*\\* within \\*\\*1 month\\*\\* prior to study enrollment",true,"ALL","18 Years","60 Years",{"count":108,"type":109},200,"ESTIMATED","INTERVENTIONAL",[112],"NA","Poniżej znajduje się bardziej płynna i mniej powtarzalna wersja tekstu:\n\nThis 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.\n\nParticipants 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.\n\nThe 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.\n\nBy 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.\n\nTa wersja eliminuje powtórzenia (\"diet\", \"study\", \"monitor\", \"effects\"), jest bardziej naturalna stylistycznie i odpowiada standardowi językowemu publikacji w czasopismach z zakresu żywienia i medycyny.",[115,116,117,118],"Nutrition","Ketogenic Diet","Gene Expression","Diet",[120,121,122,123,124,125],"ketogenic diet","gene expression","transcriptomics","biochemical parameters","stool microbiome","ketone bodies","2026-07-01",{"date":128,"type":129},"2026-07-02","ACTUAL",{"date":131,"type":129},"2024-09-02",{"date":133,"type":109},"2028-12-30",{"name":5,"class":6},2]