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Ulcerative ColitisNCT05761327

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

A study testing Mediterranean Diet, Curcumin Supplementation and Resveratrol Supplementation in people with Ulcerative Colitis, run by Ardahan University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Mediterranean Diet, Curcumin Supplementation and Resveratrol Supplementation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesTurkey (Türkiye)
Study dates
3 Jun 2022to 22 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,

Who cannot join

  • Women during pregnancy or lactation
  • Not meeting the inclusion criteria,
  • 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,

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Inonu University Turgut Ozal Medical Center

    Malatya, 44200

  • Malatya Training and Research Hospital

    Malatya, 44200

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

In the light of the information in the literature, it is seen that the level of evidence in the existing literature is insufficient with the data obtained in terms of dietary approaches and nutritional supplements to be applied to individuals with Ulcerative Colitis (UC). In addition, when the literature was examined, no randomized controlled study was found that specifically examined the effects of the Mediterranean diet and nutritional supplements combined with diet in individuals with UC, and also compared the effects of two different nutritional supplements applied in combination with diet. In this direction, the aims of this research are;

  • 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.

Being tested
Mediterranean Diet, Curcumin Supplementation, Resveratrol Supplementation
Keywords
Ulcerative Colitis, Mediterranean diet, Curcumin, Resveratrol, inflammatory bowel disease
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mediterranean DietOther

    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 SupplementationDietary 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.

  • Resveratrol SupplementationDietary supplement

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

Study groups in NCT05761327
Study groupRoleWhat they receive
Mediterranean DietActive comparatorThe 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.
Receives: Other: Mediterranean Diet
Curcumin SupplementationExperimentalIn 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.
Receives: Other: Mediterranean Diet; Dietary Supplement: Curcumin Supplementation
Resveratrol SupplementationExperimentalIn 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.
Receives: Other: Mediterranean Diet; Dietary Supplement: Resveratrol Supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

Secondary outcomes (16)

  1. 36-Item Short Form Survey (SF-36)

    It is the most frequently used quality of life scale in the medical field and consists of 8 sub-parameters with a total of 36 items that evaluate physical and mental health. These sub-parameters are physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitation, and mental health. The scores range from 0-100, with 100 points indicating the best health condition and 0 points the worst health condition.

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

  2. Truelove-Witts Severity Index

    Truelove-Witts Severity Index is a clinical classification categorizes the disease as mild, moderate, and severe, based on a combination of clinical and laboratory parameters, including bowel movements, rectal bleeding, fever, tachycardia, anemia, and increased sedimentation. The Truelove-Witts classification, using clinical symptoms, is applicable to patients with ulcerative colitis,and it is easy and reliable to use in the clinic.

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

  3. Body Mass Index

    Body weight measurements and height of the volunteers will be taken with height meter and scale. All measurements will be taken in light clothing and without shoes, according to International Standards for Anthropometric Assessment (ISAK) guidelines. Body mass index (BMI) will be calculated with weight (kg) / height (m)^2 formula. Results will be interpreted as kg/m^2.

    Measured: Change from baseline BMI at 8 weeks

  4. Waist Hip Circumference Ratio

    Non-stretchable tape measure will be used for waist and hip circumference. All measurements will be taken in light clothing and without shoes, according to International Standards for Anthropometric Assessment (ISAK) guidelines. Waist hip circumference ratio will be calculated with waist circumference (cm) / hip circumference (cm).

    Measured: Change from baseline Waist hip circumference ratio at 8 weeks

  5. Daily energy intake

    Food frequency will be evaluated by The Turkish Ministry of Health version of Food Frequency Questionnaire (FFQ). FFQ is a limited check list of foods and beverages with a frequency response section for subjects to report how often each item was consumed over the last three months. Food Record (FR) will be evaluated dietary recall. The patient will be asked to note down the foods she consumes for last 3 days. The obtained data from FFQ and FR will be entered into the BeBiS 7.1 software (BeBiS Comp., Istanbul, Turkey) and the daily energy intake(kcal) will be calculated.

    Measured: Change from baseline from the daily energy intake at 8 weeks

  6. Daily protein, fat, carbohydrate and fiber intake

    Food frequency will be evaluated by The Turkish Ministry of Health version of Food Frequency Questionnaire (FFQ). FFQ is a limited check list of foods and beverages with a frequency response section for subjects to report how often each item was consumed over the last three months. Food Record (FR) will be evaluated dietary recall. The patient will be asked to note down the foods she consumes for last 3 days. The obtained data from FFQ and FR will be entered into the BeBiS 7.1 software (BeBiS Comp., Istanbul, Turkey) and the daily protein, fat, carbohydrate, fiber (gram) intake will be calculated.

    Measured: Change from baseline from the daily protein, fat, carbohydrate and fiber intake at 8 weeks

  7. Daily vitamin and mineral intake (mg)

    Food frequency will be evaluated by The Turkish Ministry of Health version of Food Frequency Questionnaire (FFQ). FFQ is a limited check list of foods and beverages with a frequency response section for subjects to report how often each item was consumed over the last three months. Food Record (FR) will be evaluated dietary recall. The patient will be asked to note down the foods she consumes for last 3 days. The obtained data from FFQ and FR will be entered into the BeBiS 7.1 software (BeBiS Comp., Istanbul, Turkey) and the daily vitamin (E, B1, B2, niacin, C) and mineral (sodium, potassium, magnesium, phosphorus, iron, zinc) (mg) intake will be calculated.

    Measured: Change from baseline from the daily vitamin and mineral intake (mg) at 8 weeks

  8. Daily vitamin and mineral intake (mcg)

    Food frequency will be evaluated by The Turkish Ministry of Health version of Food Frequency Questionnaire (FFQ). FFQ is a limited check list of foods and beverages with a frequency response section for subjects to report how often each item was consumed over the last three months. Food Record (FR) will be evaluated dietary recall. The patient will be asked to note down the foods she consumes for last 3 days. The obtained data from FFQ and FR will be entered into the BeBiS 7.1 software (BeBiS Comp., Istanbul, Turkey) and the daily vitamin (A, D, K, Folate, B12) and mineral (iodine) (mcg) intake will be calculated.

    Measured: Change from baseline from the daily vitamin and mineral intake (mcg) at 8 weeks

  9. 24 Hour Recall Physical Activity Record

    Individuals who will participate in the research will be asked to record the physical activities they have done within 24 hours, in minutes, and to bring them to the week in which nutritional counseling will begin. Thus, after anthropometric measurements are made on the individuals, the resting metabolic rate (RMH) will be calculated with the Harris Benedict equation and the total energy requirements will be determined together with the physical activity coefficient found by using the 24-hour physical activity record.

    Measured: Pre-intervention: Beginning of the study

  10. C-Reactive Protein

    The blood tests were performed during routine controls. The C-Reactive Protein (mg/dL) biomarkers parameters to be examined.

    Measured: Change from baseline C-Reactive Protein (mg/dL) at 8 weeks.

  11. Hemoglobin

    The blood tests were performed during routine controls. The Hemoglobin (g/dL) to be examined.

    Measured: Change from baseline hemoglobin (g/dL) at 8 weeks.

  12. Mean Corpuscular Hemoglobin

    The blood tests were performed during routine controls. The Mean Corpuscular Hemoglobin (pg) parameter to be examined.

    Measured: Change from baseline Mean Corpuscular Hemoglobin (pg) at 8 weeks.

  13. Mean Platelet Volume and Platelet Distribution Width (fL)

    The blood tests were performed during routine controls. The blood biomarkers parameters to be examined are as follows:

    Mean Platelet Volume (fL) Platelet Distribution Width (fL) All blood biomarkers will be interpret separately.

    Measured: Change from baseline Mean Platelet Volume and Platelet Distribution Width (fL) at 8 weeks.

  14. Erythrocyte Sedimentation Rate (mm/hour)

    The blood tests were performed during routine controls. The blood biomarkers parameters to be examined are as follows:

    Erythrocyte Sedimentation Rate (mm/hour)

    Measured: Change from baseline Erythrocyte Sedimentation Rate (mm/hour) at 8 weeks.

  15. White blood cell and Thrombocyte (10^3/uL)

    The blood tests were performed during routine controls. The blood biomarkers parameters to be examined are as follows:

    White blood cell (10^3/uL) Thrombocyte (10^3/uL) All blood biomarkers will be interpret separately.

    Measured: Change from baseline White blood cell and Thrombocyte (10^3/uL) at 8 weeks.

  16. Blood biomarkers (%)

    The blood tests were performed during routine controls. The blood biomarkers parameters to be examined are as follows:

    Hematocrit (%) Pro-calcitonin (%) Lymphocyte (%) Monocyte (%) Neutrophil (%) Eosinophil (%) Basophil (%) Immune Globulin G (%) Platelet-Large cell ratio (%) Red Cell Distribution Width (%)

    Measured: Change from baseline blood parameters (%) at 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2023
  2. Study start3 Jun 2022
  3. Primary completion18 Feb 2023
  4. Study completion22 Mar 2024

Resources

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
Model description
Intervention Group 1: Mediterranean Diet Intervention Group 2: Mediterranean Diet + Curcumin Supplementation Intervention Group 3: Mediterranean Diet + Resveratrol Supplementation
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05761327
Sponsor's protocol ID
2021/24
Status last verified
Mar 2024
First submitted
11 Feb 2023
Last updated
25 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15168364

  • 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.

    PubMed 26316768

  • 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.

    PubMed 22001864

  • 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.

    PubMed 27741097

  • 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.

    PubMed 18724251

  • 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.

    PubMed 21530745

  • 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.

    PubMed 12472908

  • 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.

    PubMed 25724700

  • 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.

    PubMed 17101300

  • 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.

    PubMed 32888128

  • 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.

    PubMed 29191255

  • 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.

    PubMed 31802559

Questions about this trial

What is this clinical trial studying?

A study testing Mediterranean Diet, Curcumin Supplementation and Resveratrol Supplementation in people with Ulcerative Colitis, run by Ardahan University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammatory Bowel Disease Questionnaire (IBDQ) (time frame: Change from baseline Inflammatory Bowel Disease Questionnaire total score at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05761327, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.

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