Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention

NCT03792685 | Completed

• 1 other identifier: N N402 477437
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this trial are to assess the effects of interactions between genetic factors and diet with various macronutrient intake on the metabolic disorders, obesity and type 2 diabetes risk, prevention, development and progress.

Conditions

Overweight and Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome; Genetic Predisposition; Diet Modification

Outcome Measures

Primary Outcomes (6)

• The postprandial change and differences in blood glucose levels associated with investigated single nucleotide polymorphisms.

  The postprandial change and differences in blood glucose concentrations (mg/dL) will be evaluated, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.

  Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.

• The postprandial change and differences in serum insulin concentrations associated with investigated single nucleotide polymorphisms.

  The postprandial change and differences in serum insulin concentrations (IU/mL) will be evaluated, dependently on the meal type, genetic and metabolic (body weight, body fat content)

  Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.

• The change and differences in postprandial Triglycerides (TGs) concentrations associated with investigated single nucleotide polymorphisms.

  The postprandial change and differences in blood TGs (mg/dL) concentrations will be evaluated, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.

  Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.

• The change and differences in postprandial Free Fatty Acids (FFAs) concentrations associated with investigated single nucleotide polymorphisms.

  The postprandial change and differences in blood FFAs (umol/L) concentrations will be evaluated, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.

  Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.

• The change and differences in postprandial energy expenditure levels associated with investigated single nucleotide polymorphisms.

  The postprandial change and differences in energy expenditure levels (kcal/min) will be evaluated by indirect calorimetry method, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.

  Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.

• The change and differences in postprandial substrates (carbohydrate, fat and protein) utilization levels associated with investigated single nucleotide polymorphisms.

  The postprandial change and differences in substrates (carbohydrate, fat and protein) utilization (mg/min) will be evaluated by indirect calorimetry method, dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.

  Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.

Secondary Outcomes (5)

• The change and differences in postprandial ghrelin concentrations associated with investigated single nucleotide polymorphisms.

  Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.

• The change and differences in postprandial leptin concentrations associated with investigated single nucleotide polymorphisms.

  Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.

• The change and differences in postprandial adiponectin concentrations associated with investigated single nucleotide polymorphisms.

  Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.

• The change and differences in postprandial peptide YY (PYY) concentrations associated with investigated single nucleotide polymorphisms.

  Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.

• The change and differences in postprandial plasma metabolites profiles associated with investigated single nucleotide polymorphisms.

  Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.

Study Arms (3)

Normal weight

EXPERIMENTAL

Normal weight men. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.

Other: Normo-carbohydrate meal intake; Other: High-carbohydrate meal intake; Other: High-fat meal intake; Other: High-protein meal intake

Overweight/obesity

EXPERIMENTAL

Men with overweight or obesity. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.

Other: Normo-carbohydrate meal intake; Other: High-carbohydrate meal intake; Other: High-fat meal intake; Other: High-protein meal intake

Diabetes

EXPERIMENTAL

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.

Other: Normo-carbohydrate meal intake; Other: High-carbohydrate meal intake; Other: High-fat meal intake; Other: High-protein meal intake

Interventions

Normo-carbohydrate meal intake OTHER

Subjects are going to receive the normo-carbohydrate meal.

Diabetes; Normal weight; Overweight/obesity

High-carbohydrate meal intake OTHER

Subjects are going to receive the high-carbohydrate meal.

Diabetes; Normal weight; Overweight/obesity

High-fat meal intake OTHER

Subjects are going to receive the high-fat meal.

Diabetes; Normal weight; Overweight/obesity

High-protein meal intake OTHER

Subjects are going to receive the high-protein meal.

Diabetes; Normal weight; Overweight/obesity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy men with normal body weight and with overweight/obesity
• 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

You may not qualify if:

• infectious or acute diseases in the last 4 weeks before the study visits
• 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

Sponsors & Collaborators

• Medical University of Bialystok: lead
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

Clinical Research Centre, Medical University of Bialystok

Bialystok, Polska, 15-276, Poland

Location

Related Publications (20)

• 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.

  PMID: 26609520 RESULT

• 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.

  PMID: 25964024 RESULT

• 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.

  PMID: 25601634 RESULT

• 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.

  PMID: 23789315 RESULT

• 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.

  PMID: 23739212 RESULT

• 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.

  PMID: 22642073 RESULT

• 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.

  PMID: 22968341 RESULT

• 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.

  PMID: 29772667 RESULT

• 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.

  PMID: 28579156 RESULT

• 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.

  PMID: 30593267 RESULT

• 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.

  PMID: 30945034 RESULT

• 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.

  PMID: 31071580 RESULT

• 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.

  PMID: 31169260 RESULT

• 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.

  PMID: 31049566 RESULT

• 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.

  PMID: 31010169 RESULT

• 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.

  PMID: 31013777 RESULT

• 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.

  PMID: 30813625 RESULT

• 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.

  PMID: 33114268 RESULT

• 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.

  PMID: 32093387 RESULT

• 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.

  PMID: 34200102 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Disease Susceptibility; Disease Attributes; Pathologic Processes

Study Officials

• Edyta Adamska-Patruno, PhD

  Clinical Research Centre, Medical University of Bialystok

  STUDY DIRECTOR

• Maria Gorska, Prof.

  Dept of Endocrinology, Diabetology and Internal Medicine

  PRINCIPAL INVESTIGATOR

• Adam Kretowski, Prof.

  Dept of Endocrinology, Diabetology and Internal Medicine; Clinical Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: January 3, 2019
• Study Start: September 24, 2009
• Primary Completion: June 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

PL (1)