Dietary Advanced Glycation End Products, Inflammation and Oxidative Stress in Breast Cancer Patients
NCT ID: NCT04716764
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
32 participants
OBSERVATIONAL
2020-03-03
2023-06-30
Brief Summary
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Detailed Description
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The Sample Size of the Study: It was calculated by in G \* Power 3.1.9.2 the computer program. It was determined by taking into account the mean and standard deviation of the blood advanced glycation end products level variable of previous (3.3 ± 1.2 × 105 arbitrary units (AU) in breast cancer patients, 2.3 ± 0.7 × 105 AU in healthy individuals). Considering that the number of samples in the control and breast cancer groups would be equal, it was determined that both groups should consist of at least 27 individuals with an error margin of d = 1.02, α = 0.05, and a power of 0.95. Considering that there will be losses in the sample, at least 32 individuals will be included in both groups. In this study, all of the patients participating in the research are informed in detail and informed consent forms are obtained from all participants.
Statistical analysis: The data will be assessed using the SPSS 22 statistical software package. Mean, standard deviation, minimum and maximum values of the quantitative data will be calculated, and the number and percentage tables of the qualitative data will be created.
In the comparison of quantitative data of the case group (before surgery) and control group, the Student t-test will be used for the normal distribution, and the Mann-Whitney U test will be used for the non-normal distribution. The chi-squared test will be used to evaluate qualitative data.
In the comparison of quantitative data of the case group during follow-up (before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy) one-way ANOVA will be used for the normal distribution, and the Friedman test will be used for the non-normal distribution.
While determining the correlation between quantitative data, the Pearson correlation coefficient will be used for normal distribution and the Spearman correlation coefficient will be used for non-normal distribution.
The p-value \< 0.05 was considered to be statistically significant at the end of the analysis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Case Group
The study will include female individuals aged 19-64 years who applied to Necmettin Erbakan University Meram Medical Faculty General Surgery and Medical Oncology Departments and were diagnosed with breast cancer for the first time and volunteering to participate in the study. Patients with breast cancer will be followed up before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy.
3-Day Food Intake Record
Collecting clinical and socio-demographic information, nutritional status, food consumption (dietary intake of advanced glycation end products, dietary total antioxidant capacity, dietary inflammatory index), anthropometric measurements (body weight, height, body composition, handgrip strength, upper-middle arm circumference, waist circumference, hip circumference, triceps skinfold thickness), quality of life, biochemical biomarkers (serum carboxymethyl lysine, advanced glycation end products receptor, the soluble receptor of advanced glycation end products, TNF-α, IL-1β, IL-6, malondialdehyde, 2,4-dinitrophenyl hydrazine, 8-hydroxy-2'-deoxyguanosine, total antioxidant capacity)
Healthy (Control) participants
The control group consists of healthy adult women who applied to the Internal Diseases (Internal Medicine) outpatient clinic of Necmettin Erbakan University Meram Medical Faculty Hospital, who are at the same age as the case group, and who have not been diagnosed with any disease by the doctor, and who are willing to participate in the study. Healthy individuals will be interviewed once. The obtained data will be compared with the preoperative data of breast cancer patients.
3-Day Food Intake Record
Collecting clinical and socio-demographic information, nutritional status, food consumption (dietary intake of advanced glycation end products, dietary total antioxidant capacity, dietary inflammatory index), anthropometric measurements (body weight, height, body composition, handgrip strength, upper-middle arm circumference, waist circumference, hip circumference, triceps skinfold thickness), quality of life, biochemical biomarkers (serum carboxymethyl lysine, advanced glycation end products receptor, the soluble receptor of advanced glycation end products, TNF-α, IL-1β, IL-6, malondialdehyde, 2,4-dinitrophenyl hydrazine, 8-hydroxy-2'-deoxyguanosine, total antioxidant capacity)
Interventions
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3-Day Food Intake Record
Collecting clinical and socio-demographic information, nutritional status, food consumption (dietary intake of advanced glycation end products, dietary total antioxidant capacity, dietary inflammatory index), anthropometric measurements (body weight, height, body composition, handgrip strength, upper-middle arm circumference, waist circumference, hip circumference, triceps skinfold thickness), quality of life, biochemical biomarkers (serum carboxymethyl lysine, advanced glycation end products receptor, the soluble receptor of advanced glycation end products, TNF-α, IL-1β, IL-6, malondialdehyde, 2,4-dinitrophenyl hydrazine, 8-hydroxy-2'-deoxyguanosine, total antioxidant capacity)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
64 Years
FEMALE
Yes
Sponsors
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Hacettepe University
OTHER
Turkish Society of Medical Oncology
UNKNOWN
Necmettin Erbakan University
OTHER
Responsible Party
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Şenay Burçin Alkan
Lecturer
Locations
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Necmettin Erbakan University
Konya, Meram, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Alpar R. Spor, sağlık ve eğitim bilimlerinden örneklerle uygulamalı istatistik ve geçerlik-güvenirlik. Ankara: Detay Yayıncılık; 2016.
Tesarova P, Kalousova M, Jachymova M, Mestek O, Petruzelka L, Zima T. Receptor for advanced glycation end products (RAGE)--soluble form (sRAGE) and gene polymorphisms in patients with breast cancer. Cancer Invest. 2007 Dec;25(8):720-5. doi: 10.1080/07357900701560521.
Shivappa N, Hebert JR, Rosato V, Montella M, Serraino D, La Vecchia C. Association between the dietary inflammatory index and breast cancer in a large Italian case-control study. Mol Nutr Food Res. 2017 Mar;61(3):10.1002/mnfr.201600500. doi: 10.1002/mnfr.201600500. Epub 2016 Nov 30.
Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.
Carlsen MH, Halvorsen BL, Holte K, Bohn SK, Dragland S, Sampson L, Willey C, Senoo H, Umezono Y, Sanada C, Barikmo I, Berhe N, Willett WC, Phillips KM, Jacobs DR Jr, Blomhoff R. The total antioxidant content of more than 3100 foods, beverages, spices, herbs and supplements used worldwide. Nutr J. 2010 Jan 22;9:3. doi: 10.1186/1475-2891-9-3.
Demiral Y, Ergor G, Unal B, Semin S, Akvardar Y, Kivircik B, Alptekin K. Normative data and discriminative properties of short form 36 (SF-36) in Turkish urban population. BMC Public Health. 2006 Oct 9;6:247. doi: 10.1186/1471-2458-6-247.
Demirci S, Eser E, Ozsaran Z, Tankisi D, Aras AB, Ozaydemir G, Anacak Y. Validation of the Turkish versions of EORTC QLQ-C30 and BR23 modules in breast cancer patients. Asian Pac J Cancer Prev. 2011;12(5):1283-7.
Halvorsen BL, Carlsen MH, Phillips KM, Bohn SK, Holte K, Jacobs DR Jr, Blomhoff R. Content of redox-active compounds (ie, antioxidants) in foods consumed in the United States. Am J Clin Nutr. 2006 Jul;84(1):95-135. doi: 10.1093/ajcn/84.1.95.
Pellegrini N, Serafini M, Colombi B, Del Rio D, Salvatore S, Bianchi M, Brighenti F. Total antioxidant capacity of plant foods, beverages and oils consumed in Italy assessed by three different in vitro assays. J Nutr. 2003 Sep;133(9):2812-9. doi: 10.1093/jn/133.9.2812.
Pellegrini N, Serafini M, Salvatore S, Del Rio D, Bianchi M, Brighenti F. Total antioxidant capacity of spices, dried fruits, nuts, pulses, cereals and sweets consumed in Italy assessed by three different in vitro assays. Mol Nutr Food Res. 2006 Nov;50(11):1030-8. doi: 10.1002/mnfr.200600067.
Uribarri J, Woodruff S, Goodman S, Cai W, Chen X, Pyzik R, Yong A, Striker GE, Vlassara H. Advanced glycation end products in foods and a practical guide to their reduction in the diet. J Am Diet Assoc. 2010 Jun;110(6):911-16.e12. doi: 10.1016/j.jada.2010.03.018.
Wu X, Beecher GR, Holden JM, Haytowitz DB, Gebhardt SE, Prior RL. Lipophilic and hydrophilic antioxidant capacities of common foods in the United States. J Agric Food Chem. 2004 Jun 16;52(12):4026-37. doi: 10.1021/jf049696w.
Wu X, Gu L, Holden J, Haytowitz DB, Gebhardt SE, Beecher G, Prior RL. Development of a database for total antioxidant capacity in foods: a preliminary study. Journal of Food Composition and Analysis.2004; 17(3): 407-422.
Zujko ME, Witkowska AM. Antioxidant Potential and Polyphenol Content of Selected Food. International Journal of Food Properties.2011; 14(2): 300-308.
Zujko ME, Witkowska AM. Antioxidant Potential and Polyphenol Content of Beverages, Chocolates, Nuts, and Seeds. International Journal of Food Properties. 2014; 17(1): 86-92.
Other Identifiers
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dAGEs
Identifier Type: -
Identifier Source: org_study_id
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