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

NCT05761327 | Completed DMC

• 1 other identifier: 2021/24
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study was to examine and compare the effects of Mediterranean diet, curcumin supplementation with Mediterranean diet in individuals with ulcerative colitis, and resveratrol supplementation with Mediterranean diet in individuals with ulcerative colitis, on disease symptoms, quality of life, and inflammatory biomarkers.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; Mediterranean diet; Curcumin; Resveratrol; inflammatory bowel disease

Outcome Measures

Primary Outcomes (2)

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  The questionnaire consists of 32 questions and 4 subsections. These sections are; systemic symptoms (5 questions), emotional function (12 questions), social function (5 questions) and intestinal symptoms (10 questions). The questionnaire consists of a 7-point Likert scale system. For each question, 1 point indicates the highest level of exposure, and 7 indicates that there is no problem. Scores range from 32 to 224, with a higher score associated with higher quality of life. Turkish version of IBDQ will be used to assess patients' quality of life.

  Change from baseline Inflammatory Bowel Disease Questionnaire total score at 8 weeks

• Mediterranean Diet Assessment Tool (14-MEDAS)

  The Mediterranean Diet Assessment Tool will be used to measure the adherence of the participants to the Mediterranean diet. In the 14-question scale, 1 or 0 points are taken for each question asked according to the amount of consumption and these points are added. Scores are evaluated as ≤5 (low ), 6-9 (moderate), and ≥10 (high agreement).

  Change from baseline Mediterranean Diet Assessment Tool total score at 8 weeks

Secondary Outcomes (16)

• 36-Item Short Form Survey (SF-36)

  Change from baseline physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitation, and mental health scores at 8 weeks

• Truelove-Witts Severity Index

  Change from baseline Truelove-Witts Severity Index score at 8 weeks

• Body Mass Index

  Change from baseline BMI at 8 weeks

• Waist Hip Circumference Ratio

  Change from baseline Waist hip circumference ratio at 8 weeks

• Daily energy intake

  Change from baseline from the daily energy intake at 8 weeks

Study Arms (3)

Mediterranean Diet

ACTIVE COMPARATOR

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.

Other: Mediterranean Diet

Curcumin Supplementation

EXPERIMENTAL

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.

Other: Mediterranean Diet; Dietary Supplement: Curcumin Supplementation

Resveratrol Supplementation

EXPERIMENTAL

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.

Other: Mediterranean Diet; Dietary Supplement: Resveratrol Supplementation

Interventions

Mediterranean Diet OTHER

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; Mediterranean Diet; Resveratrol Supplementation

Curcumin Supplementation DIETARY_SUPPLEMENT

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.

Curcumin Supplementation

Resveratrol Supplementation DIETARY_SUPPLEMENT

Participants will take a 500mg resveratrol supplement daily. Participants are planned to use 120 capsules of resveratrol supplement during the study.

Resveratrol Supplementation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged \>18 years,
• 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,

You may not qualify if:

• Women during pregnancy or lactation
• 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,

Sponsors & Collaborators

• Ardahan University: lead

Study Sites (2)

Inonu University Turgut Ozal Medical Center

Malatya, 44200, Turkey (Türkiye)

Location

Malatya Training and Research Hospital

Malatya, 44200, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  BACKGROUND

• 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.

  PMID: 15168364 BACKGROUND

• 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.

  PMID: 26316768 BACKGROUND

• 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.

  PMID: 22001864 BACKGROUND

• 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.

  PMID: 27741097 BACKGROUND

• 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.

  PMID: 18724251 BACKGROUND

• 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.

  PMID: 21530745 BACKGROUND

• 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.

  PMID: 12472908 BACKGROUND

• 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.

  PMID: 25724700 BACKGROUND

• 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.

  PMID: 17101300 BACKGROUND

• 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.

  PMID: 32888128 BACKGROUND

• 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.

  PMID: 29191255 BACKGROUND

• 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.

  PMID: 31802559 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science, Lecturer.

Model Details: Intervention Group 1: Mediterranean Diet Intervention Group 2: Mediterranean Diet + Curcumin Supplementation Intervention Group 3: Mediterranean Diet + Resveratrol Supplementation

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: March 9, 2023
• Study Start: June 3, 2022
• Primary Completion: February 18, 2023
• Study Completion: March 22, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)