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

Last updated: March 22, 2024
Sponsor: Ardahan University
Overall Status: Completed

Phase

N/A

Condition

Ulcers

Ulcerative Colitis

Inflammatory Bowel Disease

Treatment

Curcumin Supplementation

Mediterranean Diet

Resveratrol Supplementation

Clinical Study ID

NCT05761327
2021/24
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients aged >18 years,
  • Those previously diagnosed with ulcerative colitis and/or newly diagnosed withclinical 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,

Exclusion

Exclusion Criteria:

  • 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'ssyndrome,
  • Taking one of the anti-inflammatory and antibiotic drugs,

Study Design

Total Participants: 48
Treatment Group(s): 3
Primary Treatment: Curcumin Supplementation
Phase:
Study Start date:
June 03, 2022
Estimated Completion Date:
March 22, 2024

Study 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.

Connect with a study center

  • Inonu University Turgut Ozal Medical Center

    Malatya, 44200
    Turkey

    Site Not Available

  • Malatya Training and Research Hospital

    Malatya, 44200
    Turkey

    Site Not Available

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