Ulcerative Colitis (UC)OLIVE-UC-1NCT07857447
The Effects of a Modified Mediterranean Diet on Ulcerative Colitis Patients
A study testing Modified Mediterranean Diet and Standard Nutritional Guidance in people with Ulcerative Colitis (UC), run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Modified Mediterranean Diet and Standard Nutritional Guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCroatia
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years of age)
- Endoscopically confirmed ulcerative colitis within 16 weeks prior to inclusion Clinically, by biomarkers, and/or 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/kg and/or 4)Ultrasound colon wall thickness ≥3 mm or ≥2.5 mm with presence of Doppler signal in the wall (within 14 days)
- 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).
Who cannot join
- Current use of enteral nutritional preparations
- Antibiotic use within 14 days
- Severe acute colitis
- Diabetes mellitus
- Crohn's disease
- Pregnancy
Show all 15Show fewer
- Previous major resections of digestive tract organs
- Dysphagia
- Digestive tract obstruction
- Other severe systemic or malignant disease
- Clinical eating disorder
- BMI < 16
- Avoidance of foods of animal origin (veganism)
- Irritable bowel syndrome
- Isolated proctitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
University Hospital Center Sestre milosrdnice
Zagreb, 10000
Dominik Kralj, +38513787-335, dominik.kralj@kbcsm.hr
Dominik Kralj
About this study
Official title: Galectin-3, Fecal Calprotectin and Intestinal Ultrasound for Assessing the Effects of a Modified Mediterranean Diet on Ulcerative Colitis Disease Activity
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.
Favorable 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.
Read more
The 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.
A prospective randomized study will involve participants divided into a control and an intervention group.
Over the course of 12 weeks, they will adhere to MMD under nutritionist guidance or follow standard dietary recommendations.
Read the detailed description
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.
The 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.
Galectin-3 is a protein from the lectin family associated with inflammatory and fibrotic processes. It's being investigated as a prognostic and/or diagnostic biomarker in various diseases and conditions, and its association with UC has already been demonstrated; it can be measured in serum.
Dietary habits play an important role in the prevention and treatment of numerous diseases and conditions, including UC.
Current 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.
Certain 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.
Extensive 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.
The 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.
The 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.
The 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.
The 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
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Modified Mediterranean Diet, Standard Nutritional Guidance
- Keywords
- ulcerative colitis, intestinal ultrasound, galectin-3, mediterranean diet, fecal calprotectin, ibd diet
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Mediterranean DietOther
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.
Standard Nutritional GuidanceOther
The comparator arm will receive standard nutritional guidance on the importance of a diverse diet and avoiding vitamin and mineral deficiencies.
| Study group | Role | What they receive |
|---|---|---|
| Modified Mediterranean Diet Arm | Active comparator | Not described Receives: Other: Modified Mediterranean Diet |
| Standard Nutritional Guidance Arm | Active comparator | Not described Receives: Other: Standard Nutritional Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 <=2
Measured: Week 12
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
Measured: Baseline and Week 12
Secondary outcomes (9)
Percentage of Participants Achieving Intestinal Ultrasound Remission at Week 12
The percentage of participants achieving Intestinal ultrasound remission defined as bowel wall thickness <3 mm and color doppler signal = 0
Measured: Week 12
Percentage of Participants Achieving Fecal Calprotectin Levels <50 mg/kg 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 <50 mg/kg measured at Week 12 will be reported.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominik Kralj, University Hospital Sestre Milosrdnice
- Investigators
- Alen Bišćanin, Asst. Prof. MD PhD, Study chair, University Hospital Center Sestre Milosrdnice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857447
- Sponsor's protocol ID
- 003-06/25-03/023
- Acronym
- OLIVE-UC-1
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Technical and budgeting issues are predicted to limit our ability to share IPD.
Publications
Rokkas T, Portincasa P, Koutroubakis IE. Fecal calprotectin in assessing inflammatory bowel disease endoscopic activity: a diagnostic accuracy meta-analysis. J Gastrointestin Liver Dis. 2018 Sep;27(3):299-306. doi: 10.15403/jgld.2014.1121.273.pti.
PubMed 30240474Dolinger MT, Kayal M. Intestinal ultrasound as a non-invasive tool to monitor inflammatory bowel disease activity and guide clinical decision making. World J Gastroenterol. 2023 Apr 21;29(15):2272-2282. doi: 10.3748/wjg.v29.i15.2272.
PubMed 37124889Wang F, Feng J, Gao Q, Ma M, Lin X, Liu J, Li J, Zhao Q. Carbohydrate and protein intake and risk of ulcerative colitis: Systematic review and dose-response meta-analysis of epidemiological studies. Clin Nutr. 2017 Oct;36(5):1259-1265. doi: 10.1016/j.clnu.2016.10.009. Epub 2016 Oct 15.
PubMed 27776925Haskey N, Shim RCK, Davidson-Hunt A, Ye J, Singh S, Dieleman LA, Jacobson K, Ghosh S, Gibson DL. Dietary adherence to the Mediterranean diet pattern in a randomized clinical trial of patients with quiescent ulcerative colitis. Front Nutr. 2022 Dec 21;9:1080156. doi: 10.3389/fnut.2022.1080156. eCollection 2022.
PubMed 36618690Mathews SN, Lukin DJ. Shifting the Inflammatory Balance in Ulcerative Colitis Through Diet: A Mediterranean Diet Pattern is Associated with Improvements in Dysbiosis and Disease Activity. J Crohns Colitis. 2023 Nov 8;17(10):1555-1556. doi: 10.1093/ecco-jcc/jjad095. No abstract available.
PubMed 37350629Ratajczak AE, Festa S, Aratari A, Papi C, Dobrowolska A, Krela-Kazmierczak I. Should the Mediterranean diet be recommended for inflammatory bowel diseases patients? A narrative review. Front Nutr. 2023 Jan 10;9:1088693. doi: 10.3389/fnut.2022.1088693. eCollection 2022.
PubMed 36704787Jowett SL, Seal CJ, Pearce MS, Phillips E, Gregory W, Barton JR, Welfare MR. Influence of dietary factors on the clinical course of ulcerative colitis: a prospective cohort study. Gut. 2004 Oct;53(10):1479-84. doi: 10.1136/gut.2003.024828.
PubMed 15361498Lomer MCE, Wilson B, Wall CL. British Dietetic Association consensus guidelines on the nutritional assessment and dietary management of patients with inflammatory bowel disease. J Hum Nutr Diet. 2023 Feb;36(1):336-377. doi: 10.1111/jhn.13054. Epub 2022 Jul 21.
PubMed 35735908Krznaric Z, Bender DV, Kelecic DL, Tonkic A, Cukovic-Cavka S, Mijandrusic-Sincic B, i sur. Guidelines for clinical nutrition in inflammatory bowel disease. Lijec Vjesn. 2018;140(3-4):106-19.
Gubatan J, Kulkarni CV, Talamantes SM, Temby M, Fardeen T, Sinha SR. Dietary Exposures and Interventions in Inflammatory Bowel Disease: Current Evidence and Emerging Concepts. Nutrients. 2023 Jan 22;15(3):579. doi: 10.3390/nu15030579.
PubMed 36771288Martin-Saldana S, Chevalier MT, Pandit A. Therapeutic potential of targeting galectins - A biomaterials-focused perspective. Biomaterials. 2022 Jul;286:121585. doi: 10.1016/j.biomaterials.2022.121585. Epub 2022 May 18.
PubMed 35623267Yu TB, Dodd S, Yu LG, Subramanian S. Serum galectins as potential biomarkers of inflammatory bowel diseases. PLoS One. 2020 Jan 13;15(1):e0227306. doi: 10.1371/journal.pone.0227306. eCollection 2020.
PubMed 31929564