Investigation of the Effects of Curcumin and Resveratrol Supplements Added to the Mediterranean Diet on Disease Severity and Inflammatory Biomarkers in Patients With Ulcerative Colitis
NCT ID: NCT05761327
Last Updated: 2024-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2022-06-03
2024-03-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis
NCT03122613
Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis
NCT02683759
Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis
NCT02683733
The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis
NCT03053713
Markers of Oxidative Stress in Inflammatory Bowel Diseases: Risk Factors and Implications for a Dietetic Approach
NCT04513015
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Mediterranean diet in individuals with UC,
* Curcumin supplement taken together with the Mediterranean diet in individuals with UC,
* Resveratrol supplement taken with the Mediterranean diet in individuals with UC, To examine and compare their effects on disease symptoms, quality of life and inflammatory biomarkers.
Hypotheses of the Research;
H0a: Mediterranean diet has no effect on disease symptoms, quality of life an inflammatory biomarkers in individuals with UC.
H0b: Curcumin supplementation in addition to the Mediterranean diet has no effect on disease symptoms, quality of life, and inflammatory biomarkers in individuals with UC.
H0c: Resveratrol supplementation in addition to the Mediterranean diet has no effect on disease symptoms, quality of life and inflammatory biomarkers in individuals with UC.
H0d: Three approaches including Mediterranean diet, curcumin and resveratrol supplements applied in addition to diet in individuals with UC; compared to each other in terms of disease symptoms, quality of life, and inflammatory biomarkers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mediterranean Diet
The individuals in this group will be given a nutrition model in accordance with the Mediterranean Nutrition Program under the supervision of a dietitian for 8 weeks. Individuals will be informed about the Mediterranean diet, their questions will be answered, the current food consumption record will be examined by the dietitian and they will be asked to follow the nutrition program prepared in the most appropriate way (by considering energy, nutrient requirements and nutritional habits). Every 15 days, the nutrition program will be updated with the meetings to be made by the dietitian and the patient, and the applicability of the program will be checked through daily communication.
Mediterranean Diet
In the Mediterranean diet; The frequency of consumption of foods such as olive oil, olives, nuts, fish, vegetables and fruits will be given in accordance with the Mediterranean diet pyramid. During the study, it is planned to develop new recipes suitable for the nutritional habits of the individual. The researcher will be able to reach the researcher 7/24 in case of any problem experienced by the individual, and the participant's questions will be answered. Nutrition counseling to this group will be supported by an oral explanation given by the dietitian.
Curcumin Supplementation
In addition to the Mediterranean Diet program in the 1st group for individuals in this group; 800 mg of curcumin supplement (VeNatura Curcumin Supplementary Food, Vefa, Istanbul, Turkey) will be given as 1 capsule each in the morning and evening meals.
Mediterranean Diet
In the Mediterranean diet; The frequency of consumption of foods such as olive oil, olives, nuts, fish, vegetables and fruits will be given in accordance with the Mediterranean diet pyramid. During the study, it is planned to develop new recipes suitable for the nutritional habits of the individual. The researcher will be able to reach the researcher 7/24 in case of any problem experienced by the individual, and the participant's questions will be answered. Nutrition counseling to this group will be supported by an oral explanation given by the dietitian.
Curcumin Supplementation
Participants will take a daily supplement of 1600 mg of curcumin. It is planned that the participants will use 120 capsules of curcumin supplement during the research.
Resveratrol Supplementation
In addition to the Mediterranean Diet in the 1st group for individuals in this group; 250 mg resveratrol supplement (VeNatura Resveratrol Supplementary Food, Vefa, Istanbul, Turkey) will be given as 1 capsule each in the morning and evening meals.
Mediterranean Diet
In the Mediterranean diet; The frequency of consumption of foods such as olive oil, olives, nuts, fish, vegetables and fruits will be given in accordance with the Mediterranean diet pyramid. During the study, it is planned to develop new recipes suitable for the nutritional habits of the individual. The researcher will be able to reach the researcher 7/24 in case of any problem experienced by the individual, and the participant's questions will be answered. Nutrition counseling to this group will be supported by an oral explanation given by the dietitian.
Resveratrol Supplementation
Participants will take a 500mg resveratrol supplement daily. Participants are planned to use 120 capsules of resveratrol supplement during the study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mediterranean Diet
In the Mediterranean diet; The frequency of consumption of foods such as olive oil, olives, nuts, fish, vegetables and fruits will be given in accordance with the Mediterranean diet pyramid. During the study, it is planned to develop new recipes suitable for the nutritional habits of the individual. The researcher will be able to reach the researcher 7/24 in case of any problem experienced by the individual, and the participant's questions will be answered. Nutrition counseling to this group will be supported by an oral explanation given by the dietitian.
Curcumin Supplementation
Participants will take a daily supplement of 1600 mg of curcumin. It is planned that the participants will use 120 capsules of curcumin supplement during the research.
Resveratrol Supplementation
Participants will take a 500mg resveratrol supplement daily. Participants are planned to use 120 capsules of resveratrol supplement during the study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Those previously diagnosed with ulcerative colitis and/or newly diagnosed with clinical course, consistent histology and endoscopy by a gastroenterologist,
* Mild and Moderate activity disease was confirmed by the Truelove-Witts Severity Index,
* Using a fixed dose of 5 - aminosalicylic acid (mesalazine) and/or azathioprine,
* Who did not receive nutrition therapy in the last 3 months,
* Not using anti-inflammatory drugs and antibiotic drugs in the last 4 weeks,
* Not using curcumin and resveratrol supplements before participating in the study,
* Agreeing to participate in the study voluntarily,
* History of chronic disease (such as diabetes), hypothyroidism and hyperthyroidism, liver, kidney and cardiovascular diseases, polycystic ovary syndrome and Cushing's syndrome,
* Taking one of the anti-inflammatory and antibiotic drugs,
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ardahan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Özge EROL DOĞAN
Master of Science, Lecturer.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Inonu University Turgut Ozal Medical Center
Malatya, , Turkey (Türkiye)
Malatya Training and Research Hospital
Malatya, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Judge TA LG. Inflammatory Bowel Disease. In: Friedman SL MK, Grendell JH, editor. CURRENT Diagnosis&Treatment in Gastroenterology 2th ed. America: McGraw-Hill Companies; 2003.
Sands BE. From symptom to diagnosis: clinical distinctions among various forms of intestinal inflammation. Gastroenterology. 2004 May;126(6):1518-32. doi: 10.1053/j.gastro.2004.02.072. No abstract available.
Kothari M, Mudireddy P, Swaminath A. Patient considerations in the management of ulcerative colitis - role of vedolizumab. Ther Clin Risk Manag. 2015 Aug 19;11:1235-42. doi: 10.2147/TCRM.S65650. eCollection 2015.
Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
Bernstein CN, Eliakim A, Fedail S, Fried M, Gearry R, Goh KL, Hamid S, Khan AG, Khalif I, Ng SC, Ouyang Q, Rey JF, Sood A, Steinwurz F, Watermeyer G, LeMair A; Review Team:. World Gastroenterology Organisation Global Guidelines Inflammatory Bowel Disease: Update August 2015. J Clin Gastroenterol. 2016 Nov/Dec;50(10):803-818. doi: 10.1097/MCG.0000000000000660. No abstract available.
Tozun N, Atug O, Imeryuz N, Hamzaoglu HO, Tiftikci A, Parlak E, Dagli U, Ulker A, Hulagu S, Akpinar H, Tuncer C, Suleymanlar I, Ovunc O, Hilmioglu F, Aslan S, Turkdogan K, Bahcecioglu HI, Yurdaydin C; Members of the Turkish IBD Study Group. Clinical characteristics of inflammatory bowel disease in Turkey: a multicenter epidemiologic survey. J Clin Gastroenterol. 2009 Jan;43(1):51-7. doi: 10.1097/MCG.0b013e3181574636.
Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology. 2011 May;140(6):1785-94. doi: 10.1053/j.gastro.2011.01.055.
Ardizzone S, Bianchi Porro G. Inflammatory bowel disease: new insights into pathogenesis and treatment. J Intern Med. 2002 Dec;252(6):475-96. doi: 10.1046/j.1365-2796.2002.01067.x.
Lang A, Salomon N, Wu JC, Kopylov U, Lahat A, Har-Noy O, Ching JY, Cheong PK, Avidan B, Gamus D, Kaimakliotis I, Eliakim R, Ng SC, Ben-Horin S. Curcumin in Combination With Mesalamine Induces Remission in Patients With Mild-to-Moderate Ulcerative Colitis in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015 Aug;13(8):1444-9.e1. doi: 10.1016/j.cgh.2015.02.019. Epub 2015 Feb 24.
Hanai H, Iida T, Takeuchi K, Watanabe F, Maruyama Y, Andoh A, Tsujikawa T, Fujiyama Y, Mitsuyama K, Sata M, Yamada M, Iwaoka Y, Kanke K, Hiraishi H, Hirayama K, Arai H, Yoshii S, Uchijima M, Nagata T, Koide Y. Curcumin maintenance therapy for ulcerative colitis: randomized, multicenter, double-blind, placebo-controlled trial. Clin Gastroenterol Hepatol. 2006 Dec;4(12):1502-6. doi: 10.1016/j.cgh.2006.08.008. Epub 2006 Nov 13.
Sabzevary-Ghahfarokhi M, Soltani A, Luzza F, Larussa T, Rahimian G, Shirzad H, Bagheri N. The protective effects of resveratrol on ulcerative colitis via changing the profile of Nrf2 and IL-1beta protein. Mol Biol Rep. 2020 Sep;47(9):6941-6947. doi: 10.1007/s11033-020-05753-4. Epub 2020 Sep 4.
Nunes S, Danesi F, Del Rio D, Silva P. Resveratrol and inflammatory bowel disease: the evidence so far. Nutr Res Rev. 2018 Jun;31(1):85-97. doi: 10.1017/S095442241700021X. Epub 2017 Dec 1.
Sadeghi N, Mansoori A, Shayesteh A, Hashemi SJ. The effect of curcumin supplementation on clinical outcomes and inflammatory markers in patients with ulcerative colitis. Phytother Res. 2020 May;34(5):1123-1133. doi: 10.1002/ptr.6581. Epub 2019 Dec 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021/24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.