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

Ardahan University

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Dietary Supplement: Resveratrol Supplementation; Other: Mediterranean Diet; Dietary Supplement: Curcumin Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05761327

2021/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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,

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Mediterranean Diet

Active Comparator group

Description:

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.

Treatment:

Other: Mediterranean Diet

Curcumin Supplementation

Experimental group

Description:

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.

Treatment:

Other: Mediterranean Diet

Dietary Supplement: Curcumin Supplementation

Resveratrol Supplementation

Experimental group

Description:

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.

Treatment:

Other: Mediterranean Diet

Dietary Supplement: Resveratrol Supplementation