Inflammation and Diabetes: Evaluating Antioxidant Levels (IDEAL)
The Relationship Between Dietary Antioxidant Capacity, Inflammatory Response, and Nutritional Parameters in Type 2 Diabetes Management
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Minenur Ak, BSc
- Numer telefonu: +905356549904
- E-mail: minenur.ak@bilgiedu.net
Kopia zapasowa kontaktu do badania
- Nazwa: Hande Seven Avuk, PhD
- Numer telefonu: +905303302603
- E-mail: hande.seven@bilgi.edu.tr
Lokalizacje studiów
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Istanbul, Turcja (Türkiye)
- Gaziosmanpasa Training and Research Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Adults aged 18 and older diagnosed with Type 2 Diabetes.
- Individuals whose biochemical analyses have been performed by a physician within the last 1 month.
- Individuals willing to participate voluntarily.
Exclusion Criteria:
- Missing required laboratory data in the last 1 month.
- Presence of acute infection or inflammatory disease.
- Advanced kidney or liver failure.
- Active malignancy or receiving chemotherapy/radiotherapy.
- Pregnant and lactating women.
- Use of antioxidant/vitamin-mineral supplements.
- Receiving special diet therapies (e.g., time-restricted, ketogenic, or elimination diet).
- Advanced cognitive impairment or communication difficulties.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
Interwencja / LeczenieInterwencja / Leczenie |
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Controlled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of < 7%
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Brak interwencji
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Uncontrolled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7%
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Brak interwencji
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Composite Dietary Antioxidant Index (CDAI)
Ramy czasowe: Baseline
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The Composite Dietary Antioxidant Index (CDAI) will be calculated to evaluate the total and synergistic effect of dietary antioxidants.
It is based on the standardized daily intake of six main antioxidant components: Vitamin A, Vitamin C, Vitamin E, Magnesium, Selenium, and Zinc.
Nutrient data will be obtained from food consumption records using the BeBiS 9 nutritional software.
For each antioxidant nutrient, a unitless Z-score will be calculated by subtracting the population's mean intake from the individual's intake and dividing by the standard deviation.
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Baseline
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The Dietary Antioxidant Index
Ramy czasowe: Baseline
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The Dietary Antioxidant Index (DAI) will be calculated based on the daily antioxidant intake obtained from the participants' food frequency questionnaire data.
The main dietary antioxidant components (Vitamin C, Vitamin E, $\beta$-carotene, flavonoids, and other polyphenols) will be quantitatively determined using the BeBiS 9 nutritional software.
For each antioxidant component, the obtained values will be standardized into a Z-score by subtracting the mean intake of the study population from the individual's intake and dividing by the standard deviation.
The individual's final DAI score will then be calculated by summing the Z-scores of all these components.
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Baseline
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Systemic Immune-Inflammation Index (SII)
Ramy czasowe: Baseline
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Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.
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Baseline
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Systemic Inflammation Response Index (SIRI)
Ramy czasowe: Baseline
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Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
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Baseline
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Triglyceride-Glucose (TyG) Index
Ramy czasowe: Baseline
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Calculated using fasting plasma glucose and fasting triglyceride levels as an indirect marker of insulin resistance.
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Baseline
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Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002)
Ramy czasowe: Baseline
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The nutritional risk of the participants will be evaluated using the Nutritional Risk Screening 2002 (NRS-2002) tool.
The NRS-2002 assesses impaired nutritional status and disease severity.
The total score ranges from 0 to 7. A total score of 3 or higher indicates that the patient is at nutritional risk, while a score less than 3 indicates no immediate nutritional risk.
The assessment will be administered by the researcher at the beginning of the study.
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Baseline
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Nutritional Assessment - Malnutrition Universal Screening Tool (MUST)
Ramy czasowe: Baseline
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The nutritional risk of the participants will be evaluated using the Malnutrition Universal Screening Tool (MUST).
MUST is a validated screening tool used to identify adults who are malnourished or at risk of malnutrition.
The score is calculated based on three parameters: current body mass index (BMI), unintentional weight loss, and the effect of acute disease.
The total score ranges from 0 to 6.
A score of 0 indicates low risk, a score of 1 indicates medium risk, and a score of 2 or higher indicates a high risk of malnutrition.
The assessment will be administered by the researcher at the beginning of the study.
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Baseline
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Anthropometric Measurements - Body weight (kg)
Ramy czasowe: Baseline
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At the beginning and end of the study, body weights (kg) will be measured using a weighing scales with a sensitivity of 50 grams in accordance with the measurement standards.
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Baseline
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Anthropometric Measurements - Height
Ramy czasowe: Baseline
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Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.
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Baseline
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Body Mass Index
Ramy czasowe: Baseline
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The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 form.
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Baseline
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Anthropometric Measurements - Fat Mass
Ramy czasowe: Baseline
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At the beginning and end of the study, body fat mass (kg) analysis will be performed using a bioelectrical impedanc device, paying attention to measurement standards.
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Baseline
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Body Mass Index Classification
Ramy czasowe: Baseline
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The body mass index (BMI) of the participants is classiOed according to the World Health Organization (WHO) crite ≤ 18.5 kg/m2 is underweight, between 18.5-24.99
kg/m2 is normal, ≥ 25 kg/m2 is overweight, and ≥ 30 kg/m2 is obesity.
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Baseline
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Anthropometric Measurements - Fat ratio calculation
Ramy czasowe: Baseline
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At the beginning and end of the study, body composition analyses will be performed using a bioelectrical impedanc device with measurement standards.
According to the BIA analysis, fat percentage (%) will be calculated as the rati total body fat weight to total body weight.
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Baseline
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Anthropometric Measurements - Fat-free mass
Ramy czasowe: Baseline
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At the beginning and end of the study, fat-free mass (kg) will be analyzed using a bioelectrical impedance (BIA) dev paying attention to measurement standards.
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Baseline
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Anthropometric Measurements - Muscle mass
Ramy czasowe: Baseline
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At the beginning and end of the study, lean muscle mass (kg) will be analyzed using a bioelectrical impedance (BIA paying attention to measurement standards.
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Baseline
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Anthropometric Measurements - Total body water
Ramy czasowe: Baseline
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At the beginning and end of the study, total body water (kg) will be analyzed using a bioelectrical impedance (BIA) paying attention to measurement standards.
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Baseline
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Biochemical Measurements - Platelet count (PLT)
Ramy czasowe: Baseline
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The platelet levels (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Monocyte count
Ramy czasowe: Baseline
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The monocyte levels (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Lymphocyte count (LYM)
Ramy czasowe: Baseline
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Lymphocyte count (LYM) (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Neutrophil count (NEU)
Ramy czasowe: Baseline
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Neutrophil count (NEU) (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - White blood cell (WBC)
Ramy czasowe: Baseline
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The white blood cell levels (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods fro samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - CRP
Ramy czasowe: Baseline
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Participants' c-reactive protein tests (CRP) (mg/L) will be analyzed in the hospital biochemistry laboratory using ro methods at the beginning of the study from blood samples taken by a nurse after at least 12 hours of fasting and w consuming alcohol for 24 hours before.
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Baseline
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Physical Activity Level
Ramy czasowe: Baseline
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Assessed using the International Physical Activity Questionnaire Short Form (IPAQ-Short Form) in MET-min/week.
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Baseline
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Biochemical Measurements - Fasting blood glucose
Ramy czasowe: Baseline
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Fasting blood sugar (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from bl samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurement - Lipid Profile
Ramy czasowe: Baseline
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Participants' biochemical tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, (mg/dL) will be ana the hospital biochemistry laboratory using routine methods at the beginning of the study from blood samples taken nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.
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Baseline
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Biochemical Measurements - Liver Enzymes
Ramy czasowe: Baseline
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Participants' liver enzymes tests (ALT, AST, and ALP) (IU) will be analyzed in the hospital biochemistry laboratory us routine methods at the beginning of the study from blood samples taken by a nurse after at least 12 hours of fastin without consuming alcohol for 24 hours before.
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Baseline
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Biochemical Measurements - HbA1c
Ramy czasowe: Baseline
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HbA1C will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken b nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Urea
Ramy czasowe: Baseline
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The blood urea (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Serum Albumine
Ramy czasowe: Baseline
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Serum Albumine (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from bloo samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Hemoglobin (Hb)
Ramy czasowe: Baseline
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The hemoglobin levels (g/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Hematocrit (Hct)
Ramy czasowe: Baseline
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The hematocrit levels (%) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Red blood cell count (RBC)
Ramy czasowe: Baseline
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The red blood cell levels (millions/mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Creatinine
Ramy czasowe: Baseline
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The creatinine levels (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Glomerular Filtration Rate (GFR)
Ramy czasowe: Baseline
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The glomerular filtration rate (mL/min/1.73m²)
will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
|
Baseline
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Anthropometric Measurements - Circumferences
Ramy czasowe: Baseline
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Waist, hip, neck, upper middle arm, and calf circumference measurements of the participants were measured in light clothing on an empty stomach, following anthropometric measurement standards.
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Baseline
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Anthropometric Measurements - Waist/Height Ratio
Ramy czasowe: Baseline
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Waist/height ratio will be obtained by dividing waist circumference by height at the beginning and end of the study.
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Baseline
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Anthropometric Measurements - Waist/Hip Ratio
Ramy czasowe: Baseline
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Waist/hip ratio will be obtained by dividing waist circumference by hip at the beginning and end of the study.
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Baseline
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Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Publikacje i pomocne linki
Publikacje ogólne
- Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0.
- Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
- Satia JA, Watters JL, Galanko JA. Validation of an antioxidant nutrient questionnaire in whites and African Americans. J Am Diet Assoc. 2009 Mar;109(3):502-8, 508.e1-6. doi: 10.1016/j.jada.2008.11.033.
- Kyle UG, Kossovsky MP, Karsegard VL, Pichard C. Comparison of tools for nutritional assessment and screening at hospital admission: a population study. Clin Nutr. 2006 Jun;25(3):409-17. doi: 10.1016/j.clnu.2005.11.001. Epub 2005 Dec 13.
- Hu B, Yang XR, Xu Y, Sun YF, Sun C, Guo W, Zhang X, Wang WM, Qiu SJ, Zhou J, Fan J. Systemic immune-inflammation index predicts prognosis of patients after curative resection for hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):6212-22. doi: 10.1158/1078-0432.CCR-14-0442. Epub 2014 Sep 30.
- Oztag M, Gunes FE. Validation of a food frequency questionnaire for assessing total antioxidant status. Clin Nutr ESPEN. 2022 Apr;48:351-355. doi: 10.1016/j.clnesp.2022.01.019. Epub 2022 Jan 23.
- Lin Y, Cao X, Zhu H, Chen X. Association of dietary inflammatory index, composite dietary antioxidant index, and frailty in elderly adults with diabetes. Eur J Med Res. 2024 Oct 1;29(1):480. doi: 10.1186/s40001-024-02083-0.
- Wright ME, Mayne ST, Stolzenberg-Solomon RZ, Li Z, Pietinen P, Taylor PR, Virtamo J, Albanes D. Development of a comprehensive dietary antioxidant index and application to lung cancer risk in a cohort of male smokers. Am J Epidemiol. 2004 Jul 1;160(1):68-76. doi: 10.1093/aje/kwh173.
- Simental-Mendia LE, Rodriguez-Moran M, Guerrero-Romero F. The product of fasting glucose and triglycerides as surrogate for identifying insulin resistance in apparently healthy subjects. Metab Syndr Relat Disord. 2008 Dec;6(4):299-304. doi: 10.1089/met.2008.0034.
- Qi Q, Zhuang L, Shen Y, Geng Y, Yu S, Chen H, Liu L, Meng Z, Wang P, Chen Z. A novel systemic inflammation response index (SIRI) for predicting the survival of patients with pancreatic cancer after chemotherapy. Cancer. 2016 Jul 15;122(14):2158-67. doi: 10.1002/cncr.30057. Epub 2016 May 6.
Przydatne linki
- Uyar, S., Kök, M., Ünal, A., Köker, G., Dolu, S., İnci, A., & Çekin, A. H. (2019). The validity of malnutrition universal screening tool (MUST) for nutritional screening in hemodialysis patients. Turkish Journal of Nephrology, 28(2), 109-113.
- BAPEN. (2003). The 'MUST' Explanatory Booklet: A Guide to the 'Malnutrition Universal Screening Tool' for Adults. Redditch: BAPEN.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- IDEAL (Lupus Research Alliance)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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