Clinical trial NCT05761327: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Mediterranean diet
Curcumin
Resveratrol
inflammatory bowel disease
Lead sponsor: Ardahan University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group 1: Mediterranean Diet Intervention Group 2: Mediterranean Diet + Curcumin Supplementation Intervention Group 3: Mediterranean Diet + Resveratrol Supplementation
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Change from baseline Inflammatory Bowel Disease Questionnaire total score at 8 weeks
measure: Mediterranean Diet Assessment Tool (14-MEDAS)
timeFrame: Change from baseline Mediterranean Diet Assessment Tool total score at 8 weeks
Secondary outcomes:
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Change from baseline physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitation, and mental health scores at 8 weeks
measure: Truelove-Witts Severity Index
timeFrame: Change from baseline Truelove-Witts Severity Index score at 8 weeks
measure: Body Mass Index
timeFrame: Change from baseline BMI at 8 weeks
measure: Waist Hip Circumference Ratio
timeFrame: Change from baseline Waist hip circumference ratio at 8 weeks
measure: Daily energy intake
timeFrame: Change from baseline from the daily energy intake at 8 weeks
measure: Daily protein, fat, carbohydrate and fiber intake
timeFrame: Change from baseline from the daily protein, fat, carbohydrate and fiber intake at 8 weeks
measure: Daily vitamin and mineral intake (mg)
timeFrame: Change from baseline from the daily vitamin and mineral intake (mg) at 8 weeks
measure: Daily vitamin and mineral intake (mcg)
timeFrame: Change from baseline from the daily vitamin and mineral intake (mcg) at 8 weeks
measure: 24 Hour Recall Physical Activity Record
timeFrame: Pre-intervention: Beginning of the study
measure: C-Reactive Protein
timeFrame: Change from baseline C-Reactive Protein (mg/dL) at 8 weeks.
measure: Hemoglobin
timeFrame: Change from baseline hemoglobin (g/dL) at 8 weeks.
measure: Mean Corpuscular Hemoglobin
timeFrame: Change from baseline Mean Corpuscular Hemoglobin (pg) at 8 weeks.
measure: Mean Platelet Volume and Platelet Distribution Width (fL)
timeFrame: Change from baseline Mean Platelet Volume and Platelet Distribution Width (fL) at 8 weeks.
measure: Erythrocyte Sedimentation Rate (mm/hour)
timeFrame: Change from baseline Erythrocyte Sedimentation Rate (mm/hour) at 8 weeks.
measure: White blood cell and Thrombocyte (10^3/uL)
timeFrame: Change from baseline White blood cell and Thrombocyte (10^3/uL) at 8 weeks.
measure: Blood biomarkers (%)
timeFrame: Change from baseline blood parameters (%) at 8 weeks.
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University Turgut Ozal Medical Center
city: Malatya
country: Turkey
facility: Malatya Training and Research Hospital
Study officials:
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