[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658890":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":61,"studyPopulation":57,"armGroups":62,"interventions":72,"overallOfficials":81,"centralContacts":86,"locations":95,"responsibleParty":112,"collaborators":57,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":57,"enrollmentInfo":124,"targetDuration":57,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":140,"whyStopped":57,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"University Hospital Sestre Milosrdnice","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":45},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants Achieving Clinical Remission per Simple Clinical Colitis Activity Index (SCCAI) at Week 12","The percentage of participants achieving clinical remission as defined by SCCAI \\\u003C=2","Week 12",{"measure":14,"description":15,"timeFrame":16},"Mean change of serum levels of Galectin-3 in study participants","Measuring Galectin-3 levels in the serum of participants at Baseline and Week 12 to assess correlation with disease activity","Baseline and Week 12",[18,21,24,27,30,33,36,39,42],{"measure":19,"description":20,"timeFrame":12},"Percentage of Participants Achieving Intestinal Ultrasound Remission at Week 12","The percentage of participants achieving Intestinal ultrasound remission defined as bowel wall thickness \\\u003C3 mm and color doppler signal = 0",{"measure":22,"description":23,"timeFrame":16},"Percentage of Participants Achieving Fecal Calprotectin Levels \u003C50 mg\u002Fkg at Week 12","Fecal calprotectin will be measured in stool samples of participants at baseline and Week 12. The percentage of patients achieving fecal calprotectin \\\u003C50 mg\u002Fkg measured at Week 12 will be reported.",{"measure":25,"description":26,"timeFrame":16},"Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12","The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The mean change from baseline in IBDQ score will be presented.",{"measure":28,"description":29,"timeFrame":16},"Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12","The FACIT-Fatigue assesses self-reported fatigue and its impact upon daily activities and function. The mean change from baseline in FACIT-Fatigue score will be presented.",{"measure":31,"description":32,"timeFrame":16},"Mean Change From Baseline in The 36-item Short Form Health Survey (SF-36) Score","SF-36 is a measure of health-related quality-of-life. The mean change from baseline in SF-36 will be presented.",{"measure":34,"description":35,"timeFrame":16},"Mean Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) at Week 12","The EQ-VAS is a vertical visual analogue scale used as valid measure for self-assessed general health status. The mean change from baseline in EQ-VAS will be presented.",{"measure":37,"description":38,"timeFrame":16},"Mean Change From Baseline in Mediterranean Diet Adherence Score (MEDAS) at Week 12","The MEDAS Score is a 14-item questionnaire used to measure how closely a person follows the traditional Mediterranean diet. The mean change from baseline in MEDAS score will be presented.",{"measure":40,"description":41,"timeFrame":16},"Mean Change From Baseline in Mediterranean Dietary Serving Score (MDSS) at Week 12","MDSS is a tool that measures how closely a person follows the Mediterranean diet. The mean change from baseline in MDSS will be presented.",{"measure":43,"description":44,"timeFrame":16},"Assessment of frequency of consumption and usual portion sizes of particular food groups using the Food Frequency Questionnaire (FFQ) at Baseline and Week 12","A food frequency questionnaire (FFQ) is used to determine the frequency of consumption and usual portion sizes of different food groups consumed in the prespecified period. It is used to assess how the participants' dietary habits change throughout the study and evaluate dietary adherence.",[46,50],{"measure":47,"description":48,"timeFrame":49},"Exploratory Digital Biomarkers","Scanning the Tongue, Oral Cavity, and Other Facial Biomarkers:\n\nThis involves using a smartphone camera and a multispectral device to analyze parameters like color, texture, glossitis, and other changes in the oral cavity and the rest of the face. These changes can be linked to inflammation or general health status. The technology allows for the detection of subtle changes in real-time, which can improve disease monitoring.","From enrollment to the end of intervention at 12 weeks",{"measure":51,"description":52,"timeFrame":53},"Exploratory multiomics - microbiological, genetic, and epigenetic analyses of blood, stool and oral swab samples.","Collection of Biological Samples:\n\nBlood - taking samples for the analysis of biomarkers related to inflammation and immune functions, as well as genetic and epigenetic analyses.\n\nStool - collecting samples for microbiological, genetic, and epigenetic analyses.\n\nOral swab sample - collecting oral swab samples for microbiological, genetic, and epigenetic analyses.","At enrollment and at the end of intervention at 12 weeks",{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":57,"timePerspective":57,"maskingInfo":59},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":60,"maskingDescription":57,"whoMasked":57},"NONE","Ulcerative colitis (UC) is a chronic, inflammatory, non-contagious disease affecting the mucosa of the large intestine and rectum characterized by periods of exacerbation and remission. While the exact causes of UC aren't fully understood, the disease's etiology is linked to a complex interaction of genetic, immunological, and environmental factors, including gut microbiota dysbiosis. Therapeutic approaches for UC aim to reduce inflammation, control symptoms, maintain remission, and improve patients' quality of life. Key therapeutic approaches include aminosalicylates, glucocorticoids, immunosuppressants, biological therapy, and small molecules.\n\nThe gold standard for monitoring disease activity and treatment response is endoscopy, supplemented by fecal calprotectin and C-reactive protein as biomarkers, and intestinal ultrasound as an imaging method. Given the invasive nature of endoscopy in assessing disease activity, there's an increasing emphasis on non-invasive monitoring methods. These are often insufficient, highlighting a need for new inflammatory markers.\n\nGalectin-3 is a protein from the lectin family associated with inflammatory and fibrotic processes. It's being investigated as a prognostic and\u002For diagnostic biomarker in various diseases and conditions, and its association with UC has already been demonstrated; it can be measured in serum.\n\nDietary habits play an important role in the prevention and treatment of numerous diseases and conditions, including UC.\n\nCurrent European and Croatian guidelines for nutrition in patients with inflammatory bowel disease emphasize recognizing malnutrition and meeting the body's nutritional needs through enteral and parenteral support, along with individual mineral and element supplementation. However, these guidelines don't single out any specific dietary pattern for inducing or maintaining disease remission. Patients have clearly expressed a need for dietary counseling and often independently adopt restrictive dietary patterns without consulting a doctor or nutritionist. Doctors are limited by restricted evidence for specific dietary approaches, lack adequate nutritional knowledge, and are constrained by the time they can dedicate to individual patients.\n\nCertain dietary components, prevalent in the Western dietary pattern, such as highly processed foods, trans-fatty acids, refined sugars, and increased red meat intake, have been identified as factors associated with the onset and worsening of bowel diseases. The dietary effect is achieved by restricting, adding, or changing the ratio of certain food groups or specific dietary supplements, which impacts the intestinal mucosa, gut permeability, and microbiota composition. It is precisely the microbiota changes induced by dietary interventions that are the probable mechanism of effect on disease activity, as has already been shown in several studies, as well as through the use of probiotics and fecal transplantation. The literature recognizes that conducting dietary interventions within clinical trials is challenging, resulting in a small number of publications on the topic, most of which involve small sample sizes and retrospective study designs.\n\nExtensive literature data exist on the favorable effects of the Mediterranean Diet (MD) on numerous diseases and conditions. According to the results of a recent meta-analysis of the human microbiome on a Mediterranean diet, a favorable influence on the diversity and abundance of anti-inflammatory bacterial strains has been shown compared to the microbiota of individuals with inflammatory bowel disease or colorectal cancer. The authors conclude that modulation of the gut microbiota through diet plays a role in the prevention of colon diseases.\n\nThe Mediterranean diet has proven to be one dietary approach that can positively impact individuals suffering from ulcerative colitis. To date, several studies have explored the impact of MD on UC activity with favorable outcomes. However, in all cases, these involved very small numbers of patients with retrospective study designs and disease activity assessed solely based on symptoms, without objective evaluation of the response to intervention. A study by Huskey et al. on 28 UC patients in remission on stable therapy, randomized to a Mediterranean eating style or a usual Canadian diet, showed improvement in intestinal symptoms after 12 weeks of dietary intervention with good dietary adherence. A recent prospective randomized study on 66 UC patients demonstrated a favorable effect of a combination of fecal transplantation and an anti-inflammatory diet compared to standard treatment for inducing and maintaining disease remission.\n\nThe MD is based on a traditional dietary pattern characteristic of Mediterranean countries. Its key features include: increased intake of fruits and vegetables (providing antioxidants, vitamins, and minerals), olive oil as the main fat source (rich in monounsaturated fatty acids), whole grains (rich in fiber for a positive balance of intestinal microflora), along with limited red meat intake compared to poultry and fish, and moderate consumption of dairy products.\n\nThe dietary intake of carbohydrates and their impact on human health has been widely researched in numerous indications, including inflammatory bowel diseases. According to meta-analyses, a high intake of carbohydrates has not been shown to increase the risk of developing UC, but it's important to note that most of these studies include dietary fiber in the total carbohydrate content. The beneficial effect of dietary fiber is recognized in modifying the gut microbiota, which can prevent the onset of UC and positively influence the maintenance of disease remission. A newer study by Fritsch et al. showed a favorable impact and good tolerance of a high-fiber diet in 17 patients with UC in disease remission. A recent systematic analysis indicated that a gluten-free diet and a low-FODMAP diet favorably affect the quality of life of UC patients, but not necessarily clinically significant outcomes. Reduced carbohydrate intake aimed at achieving ketosis for an anti-inflammatory effect is a subject of intense study in recent years, especially in neurological diseases and rheumatology, but it has not been adequately investigated in UC.\n\nThe Simple Clinical Colitis Activity Index (SCCAI) is used in numerous studies to assess the clinical activity of UC. Intestinal ultrasound is an established and increasingly widespread method for monitoring UC patients in clinical practice. The main ultrasound characteristics of the intestine during an inflammatory process are bowel wall thickness, bowel wall stratification, presence of Doppler signal in the wall, and presence of inflammatory reaction in the surrounding mesenteric fat tissue. Fecal calprotectin is an established monitoring method in inflammatory bowel diseases with high specificity and sensitivity for assessing disease activity",[63,68],{"label":64,"type":65,"description":57,"interventionNames":66},"Modified Mediterranean Diet Arm","ACTIVE_COMPARATOR",[67],"Other: Modified Mediterranean Diet",{"label":69,"type":65,"description":57,"interventionNames":70},"Standard Nutritional Guidance Arm",[71],"Other: Standard Nutritional Guidance",[73,77],{"type":6,"name":74,"description":75,"armGroupLabels":76,"otherNames":57},"Modified Mediterranean Diet","A Modified Mediterranean Diet with reduced carbohydrate content and preserved fibre content will be used in the primary intervention group. The participants randomized to this group will receive a weekly meal plan based on personalized nutritional assessment.",[64],{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":57},"Standard Nutritional Guidance","The comparator arm will receive standard nutritional guidance on the importance of a diverse diet and avoiding vitamin and mineral deficiencies.",[69],[82],{"name":83,"affiliation":84,"role":85},"Alen Bišćanin, Asst. Prof. MD PhD","University Hospital Center Sestre Milosrdnice","STUDY_CHAIR",[87,92],{"name":88,"role":89,"phone":90,"phoneExt":57,"email":91},"Dominik Kralj","CONTACT","+38513787-335","dominik.kralj@kbcsm.hr",{"name":83,"role":89,"phone":93,"phoneExt":57,"email":94},"+38513787-625","alen.biscanin@kbcsm.hr",[96],{"facility":97,"status":57,"city":98,"state":57,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"University Hospital Center Sestre milosrdnice","Zagreb","10000","Croatia","HR",{"type":103,"coordinates":104},"Point",[105,106],15.97798,45.81444,{"lat":106,"lon":105},[109,110],{"name":88,"role":89,"phone":90,"phoneExt":57,"email":91},{"name":88,"role":111,"phone":57,"phoneExt":57,"email":57},"PRINCIPAL_INVESTIGATOR",{"type":111,"investigatorFullName":88,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"MD","100658890","the-effects-of-a-modified-mediterranean-diet-on-ulcerative-colitis-patients-100658890",false,"NCT07857447","The Effects of a Modified Mediterranean Diet on Ulcerative Colitis Patients","Galectin-3, Fecal Calprotectin and Intestinal Ultrasound for Assessing the Effects of a Modified Mediterranean Diet on Ulcerative Colitis Disease Activity","OLIVE-UC-1","Inclusion Criteria:\n\n* Adult patients (\\>18 years of age)\n* Endoscopically confirmed ulcerative colitis within 16 weeks prior to inclusion Clinically, by biomarkers, and\u002For by ultrasound, active mild to moderate disease (within 14 days) defined as: 1) SCCAI (Simple Clinical Colitis Activity Index) 3-9 and 2)Calprotectin ≥150 mg\u002Fkg and\u002For 4)Ultrasound colon wall thickness ≥3 mm or ≥2.5 mm with presence of Doppler signal in the wall (within 14 days)\n* Stable dose of immunosuppressants, small molecules, or aminosalicylates for the past 4 weeks or Stable use of biological therapy for the past 16 weeks or Currently taking oral glucocorticoids at a dose up to 20 mg methylprednisolone (equivalent to 25 mg prednisone) with mandatory dose reduction after inclusion in the study (reduction of 4 mg methylprednisolone every 7 days or equivalent).\n\nExclusion Criteria:\n\n* Current use of enteral nutritional preparations\n* Antibiotic use within 14 days\n* Severe acute colitis\n* Diabetes mellitus\n* Crohn's disease\n* Pregnancy\n* Previous major resections of digestive tract organs\n* Dysphagia\n* Digestive tract obstruction\n* Other severe systemic or malignant disease\n* Clinical eating disorder\n* BMI \\\u003C 16\n* Avoidance of foods of animal origin (veganism)\n* Irritable bowel syndrome\n* Isolated proctitis","ALL","18 Years",{"count":125,"type":126},62,"ESTIMATED","INTERVENTIONAL",[129],"NA","Ulcerative colitis is a chronic disease with a significant impact on quality of life where a substantial proportion of patients fails to achieve disease remission. It is a multifactorial disease, and the influence of diet on its onset and course remains underexplored.\n\nFavorable effects of the Mediterranean diet on numerous diseases have been confirmed in clinical research, but in the case of ulcerative colitis, there is a lack of well-designed studies.\n\nThe aim of this study is to demonstrate that a modified Mediterranean diet (MMD) with reduced carbohydrate intake over a duration of 12 weeks, in conjunction with standard therapy, has a favorable impact on symptoms and objective markers of inflammation in ulcerative colitis patients.\n\nA prospective randomized study will involve participants divided into a control and an intervention group.\n\nOver the course of 12 weeks, they will adhere to MMD under nutritionist guidance or follow standard dietary recommendations.",[132],"Ulcerative Colitis (UC)",[134,135,136,137,138,139],"ulcerative colitis","intestinal ultrasound","galectin-3","mediterranean diet","fecal calprotectin","ibd diet","NOT_YET_RECRUITING","2026-09-30",{"date":143,"type":144},"2026-10-05","ACTUAL",{"date":146,"type":126},"2026-10",{"date":148,"type":126},"2027-12",{"name":5,"class":6},1]