Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University Turgut Ozal Medical Center, Malatya, Turkey (Türkiye)

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Mediterranean Diet

Other

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 Supplementation

Dietary 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 Supplementation

Dietary Supplement

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

Primary outcomes

  1. Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: 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.

  2. Mediterranean Diet Assessment Tool (14-MEDAS)

    Time frame: 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).

Secondary outcomes

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

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

    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.

  2. Truelove-Witts Severity Index

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

    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.

  3. Body Mass Index

    Time frame: Change from baseline BMI at 8 weeks

    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.

  4. Waist Hip Circumference Ratio

    Time frame: Change from baseline Waist hip circumference ratio at 8 weeks

    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).

  5. Daily energy intake

    Time frame: Change from baseline from the daily energy intake at 8 weeks

    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.

  6. Daily protein, fat, carbohydrate and fiber intake

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

    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.

  7. Daily vitamin and mineral intake (mg)

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

    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.

  8. Daily vitamin and mineral intake (mcg)

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

    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.

  9. 24 Hour Recall Physical Activity Record

    Time frame: Pre-intervention: Beginning of the study

    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.

  10. C-Reactive Protein

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

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

  11. Hemoglobin

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

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

  12. Mean Corpuscular Hemoglobin

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

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

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

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

    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.

  14. Erythrocyte Sedimentation Rate (mm/hour)

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

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

    Erythrocyte Sedimentation Rate (mm/hour)

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

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

    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.

  16. Blood biomarkers (%)

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

    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 (%)

Sponsors and collaborators

Lead sponsor

Ardahan University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 9, 2023
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.