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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Inflammatory Bowel Disease Questionnaire (IBDQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
排除标准
- •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,
研究组 & 干预措施
Mediterranean Diet
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.
干预措施: Mediterranean Diet (Other)
Curcumin Supplementation
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.
干预措施: Mediterranean Diet (Other)
Curcumin Supplementation
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.
干预措施: Curcumin Supplementation (Dietary Supplement)
Resveratrol Supplementation
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.
干预措施: Mediterranean Diet (Other)
Resveratrol Supplementation
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.
干预措施: Resveratrol Supplementation (Dietary Supplement)
结局指标
主要结局
Inflammatory Bowel Disease Questionnaire (IBDQ)
时间窗: Change from baseline Inflammatory Bowel Disease Questionnaire total score at 8 weeks
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.
Mediterranean Diet Assessment Tool (14-MEDAS)
时间窗: Change from baseline Mediterranean Diet Assessment Tool total score at 8 weeks
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).
次要结局
- 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)
- Body Mass Index(Change from baseline BMI at 8 weeks)
- Daily protein, fat, carbohydrate and fiber intake(Change from baseline from the daily protein, fat, carbohydrate and fiber intake at 8 weeks)
- Mean Corpuscular Hemoglobin(Change from baseline Mean Corpuscular Hemoglobin (pg) 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)
- Mean Platelet Volume and Platelet Distribution Width (fL)(Change from baseline Mean Platelet Volume and Platelet Distribution Width (fL) at 8 weeks.)
- 24 Hour Recall Physical Activity Record(Pre-intervention: Beginning of the study)
- C-Reactive Protein(Change from baseline C-Reactive Protein (mg/dL) at 8 weeks.)
- Hemoglobin(Change from baseline hemoglobin (g/dL) at 8 weeks.)
- Blood biomarkers (%)(Change from baseline blood parameters (%) at 8 weeks.)
- Daily vitamin and mineral intake (mcg)(Change from baseline from the daily vitamin and mineral intake (mcg) at 8 weeks)
- Truelove-Witts Severity Index(Change from baseline Truelove-Witts Severity Index score at 8 weeks)
- Daily vitamin and mineral intake (mg)(Change from baseline from the daily vitamin and mineral intake (mg) at 8 weeks)
- Erythrocyte Sedimentation Rate (mm/hour)(Change from baseline Erythrocyte Sedimentation Rate (mm/hour) at 8 weeks.)
- White blood cell and Thrombocyte (10^3/uL)(Change from baseline White blood cell and Thrombocyte (10^3/uL) at 8 weeks.)
研究者
Özge EROL DOĞAN
Master of Science, Lecturer.
Ardahan University