Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention
NCT ID: NCT03792685
Last Updated: 2021-02-21
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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COMPLETED
NA
150 participants
INTERVENTIONAL
2009-09-24
2021-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Normal weight
Normal weight men. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.
Normo-carbohydrate meal intake
Subjects are going to receive the normo-carbohydrate meal.
High-carbohydrate meal intake
Subjects are going to receive the high-carbohydrate meal.
High-fat meal intake
Subjects are going to receive the high-fat meal.
High-protein meal intake
Subjects are going to receive the high-protein meal.
Overweight/obesity
Men with overweight or obesity. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.
Normo-carbohydrate meal intake
Subjects are going to receive the normo-carbohydrate meal.
High-carbohydrate meal intake
Subjects are going to receive the high-carbohydrate meal.
High-fat meal intake
Subjects are going to receive the high-fat meal.
High-protein meal intake
Subjects are going to receive the high-protein meal.
Diabetes
Men with prediabetes or type 2 diabetes mellitus. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.
Normo-carbohydrate meal intake
Subjects are going to receive the normo-carbohydrate meal.
High-carbohydrate meal intake
Subjects are going to receive the high-carbohydrate meal.
High-fat meal intake
Subjects are going to receive the high-fat meal.
High-protein meal intake
Subjects are going to receive the high-protein meal.
Interventions
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Normo-carbohydrate meal intake
Subjects are going to receive the normo-carbohydrate meal.
High-carbohydrate meal intake
Subjects are going to receive the high-carbohydrate meal.
High-fat meal intake
Subjects are going to receive the high-fat meal.
High-protein meal intake
Subjects are going to receive the high-protein meal.
Eligibility Criteria
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Inclusion Criteria
* men with metabolic syndrome, hypertension, type 2 diabetes newly diagnosed, or not treated with any medicines
* maintaining the usual diet and lifestyle throughout the study
Exclusion Criteria
* any medicines/dietary supplements consumption in the last 4 weeks before the study visits
* high level of daily physical activity
* the following any special diet or dietary patterns (vegetarian, high-fat etc.)
* the presence of any other significant disease which may affect the results (hormonal disorders, history of any surgeries on gastrointestinal tract, allergies known or suspected, heart failure, history of cancer, any kidney, pancrea and liver diseases, except non-alcoholic fatty liver)
* abusive alcohol consumption
* abusive coffee or energy drinks consumption
* drug consumption
18 Years
65 Years
MALE
Yes
Sponsors
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Ministry of Science and Higher Education, Poland
OTHER_GOV
Medical University of Bialystok
OTHER
Responsible Party
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Principal Investigators
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Edyta Adamska-Patruno, PhD
Role: STUDY_DIRECTOR
Clinical Research Centre, Medical University of Bialystok
Maria Gorska, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dept of Endocrinology, Diabetology and Internal Medicine
Adam Kretowski, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dept of Endocrinology, Diabetology and Internal Medicine; Clinical Research Centre
Locations
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Clinical Research Centre, Medical University of Bialystok
Bialystok, Polska, Poland
Countries
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References
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Adamska E, Ostrowska L, Goscik J, Waszczeniuk M, Kretowski A, Gorska M. Intake of Meals Containing High Levels of Carbohydrates or High Levels of Unsaturated Fatty Acids Induces Postprandial Dysmetabolism in Young Overweight/Obese Men. Biomed Res Int. 2015;2015:147196. doi: 10.1155/2015/147196. Epub 2015 Nov 2.
Ciborowski M, Adamska E, Rusak M, Godzien J, Wilk J, Citko A, Bauer W, Gorska M, Kretowski A. CE-MS-based serum fingerprinting to track evolution of type 2 diabetes mellitus. Electrophoresis. 2015 Sep;36(18):2286-2293. doi: 10.1002/elps.201500021. Epub 2015 Jun 26.
Kretowski A, Adamska E, Maliszewska K, Wawrusiewicz-Kurylonek N, Citko A, Goscik J, Bauer W, Wilk J, Golonko A, Waszczeniuk M, Lipinska D, Hryniewicka J, Niemira M, Paczkowska M, Ciborowski M, Gorska M. The rs340874 PROX1 type 2 diabetes mellitus risk variant is associated with visceral fat accumulation and alterations in postprandial glucose and lipid metabolism. Genes Nutr. 2015 Mar;10(2):4. doi: 10.1007/s12263-015-0454-6. Epub 2015 Jan 20.
Ostrowska L, Fiedorczuk J, Adamska E. Effect of diet and other factors on serum adiponectin concentrations in patients with type 2 diabetes. Rocz Panstw Zakl Hig. 2013;64(1):61-6.
Ostrowska L, Witczak K, Adamska E. Effect of nutrition and atherogenic index on the occurrence and intensity of insulin resistance. Pol Arch Med Wewn. 2013;123(6):289-96. doi: 10.20452/pamw.1774. Epub 2013 Jun 5.
Adamska E, Ostrowska L, Adamska E, Maliszewska K, Citko A, Waszczeniuk M, Przystupa W, Majewski R, Wasilewska A, Milewski R, Krytowski A, Gorska M. [Differences in dietary habits and food preferences of adults depending on the age]. Rocz Panstw Zakl Hig. 2012;63(1):73-81. Polish.
Adamska E, Waszczeniuk M, Goscik J, Golonko A, Wilk J, Pliszka J, Maliszewska K, Lipinska D, Milewski R, Wasilewska A, Citko A, Nikolajuk A, Ostrowska L, Kretowski A, Gorska M. The usefulness of glycated hemoglobin A1c (HbA1c) for identifying dysglycemic states in individuals without previously diagnosed diabetes. Adv Med Sci. 2012;57(2):296-301. doi: 10.2478/v10039-012-0030-x.
Adamska-Patruno E, Ostrowska L, Golonko A, Pietraszewska B, Goscik J, Kretowski A, Gorska M. Evaluation of Energy Expenditure and Oxidation of Energy Substrates in Adult Males after Intake of Meals with Varying Fat and Carbohydrate Content. Nutrients. 2018 May 16;10(5):627. doi: 10.3390/nu10050627.
Adamska E, Kretowski A, Goscik J, Citko A, Bauer W, Waszczeniuk M, Maliszewska K, Paczkowska-Abdulsalam M, Niemira M, Szczerbinski L, Ciborowski M, Gorska M. The type 2 diabetes susceptibility TCF7L2 gene variants affect postprandial glucose and fat utilization in non-diabetic subjects. Diabetes Metab. 2018 Sep;44(4):379-382. doi: 10.1016/j.diabet.2017.05.001. Epub 2017 May 31. No abstract available.
Adamska-Patruno E, Ostrowska L, Goscik J, Pietraszewska B, Kretowski A, Gorska M. The relationship between the leptin/ghrelin ratio and meals with various macronutrient contents in men with different nutritional status: a randomized crossover study. Nutr J. 2018 Dec 28;17(1):118. doi: 10.1186/s12937-018-0427-x.
Adamska-Patruno E, Goscik J, Czajkowski P, Maliszewska K, Ciborowski M, Golonko A, Wawrusiewicz-Kurylonek N, Citko A, Waszczeniuk M, Kretowski A, Gorska M. The MC4R genetic variants are associated with lower visceral fat accumulation and higher postprandial relative increase in carbohydrate utilization in humans. Eur J Nutr. 2019 Oct;58(7):2929-2941. doi: 10.1007/s00394-019-01955-0. Epub 2019 Apr 3.
Godzien J, Kalaska B, Adamska-Patruno E, Siroka J, Ciborowski M, Kretowski A, Barbas C. Oxidized glycerophosphatidylcholines in diabetes through non-targeted metabolomics: Their annotation and biological meaning. J Chromatogr B Analyt Technol Biomed Life Sci. 2019 Jul 1;1120:62-70. doi: 10.1016/j.jchromb.2019.04.053. Epub 2019 Apr 29.
Szczerbinski L, Goscik J, Bauer W, Wawrusiewicz-Kurylonek N, Paczkowska-Abdulsalam M, Niemira M, Citko A, Adamska-Patruno E, Gorska M, Kretowski A. Efficacy of family history, genetic risk score, and physical activity in assessing the prevalence of type 2 diabetes. Pol Arch Intern Med. 2019 Aug 29;129(7-8):442-450. doi: 10.20452/pamw.14866. Epub 2019 Jun 6.
Adamska-Patruno E, Samczuk P, Ciborowski M, Godzien J, Pietrowska K, Bauer W, Gorska M, Barbas C, Kretowski A. Metabolomics Reveal Altered Postprandial Lipid Metabolism After a High-Carbohydrate Meal in Men at High Genetic Risk of Diabetes. J Nutr. 2019 Jun 1;149(6):915-922. doi: 10.1093/jn/nxz024.
Adamska-Patruno E, Godzien J, Ciborowski M, Samczuk P, Bauer W, Siewko K, Gorska M, Barbas C, Kretowski A. The Type 2 Diabetes Susceptibility PROX1 Gene Variants Are Associated with Postprandial Plasma Metabolites Profile in Non-Diabetic Men. Nutrients. 2019 Apr 19;11(4):882. doi: 10.3390/nu11040882.
Maliszewska K, Adamska-Patruno E, Goscik J, Lipinska D, Citko A, Krahel A, Miniewska K, Fiedorczuk J, Moroz M, Gorska M, Kretowski A. The Role of Muscle Decline in Type 2 Diabetes Development: A 5-Year Prospective Observational Cohort Study. Nutrients. 2019 Apr 12;11(4):834. doi: 10.3390/nu11040834.
Adamska-Patruno E, Ostrowska L, Goscik J, Fiedorczuk J, Moroz M, Kretowski A, Gorska M. The Differences in Postprandial Serum Concentrations of Peptides That Regulate Satiety/Hunger and Metabolism after Various Meal Intake, in Men with Normal vs. Excessive BMI. Nutrients. 2019 Feb 26;11(3):493. doi: 10.3390/nu11030493.
Czajkowski P, Adamska-Patruno E, Bauer W, Fiedorczuk J, Krasowska U, Moroz M, Gorska M, Kretowski A. The Impact of FTO Genetic Variants on Obesity and Its Metabolic Consequences is Dependent on Daily Macronutrient Intake. Nutrients. 2020 Oct 23;12(11):3255. doi: 10.3390/nu12113255.
Paczkowska-Abdulsalam M, Niemira M, Bielska A, Szalkowska A, Raczkowska BA, Junttila S, Gyenesei A, Adamska-Patruno E, Maliszewska K, Citko A, Szczerbinski L, Kretowski A. Evaluation of Transcriptomic Regulations behind Metabolic Syndrome in Obese and Lean Subjects. Int J Mol Sci. 2020 Feb 20;21(4):1455. doi: 10.3390/ijms21041455.
Bauer W, Adamska-Patruno E, Krasowska U, Moroz M, Fiedorczuk J, Czajkowski P, Bielska D, Gorska M, Kretowski A. Dietary Macronutrient Intake May Influence the Effects of TCF7L2 rs7901695 Genetic Variants on Glucose Homeostasis and Obesity-Related Parameters: A Cross-Sectional Population-Based Study. Nutrients. 2021 Jun 4;13(6):1936. doi: 10.3390/nu13061936.
Other Identifiers
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N N402 477437
Identifier Type: -
Identifier Source: org_study_id
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