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.
This is a randomized, crossover study that includes 1 screening visit and four meal challenge test visits, separated by a 1-2-weeks washout period. The screening will include 2000 people, males and females, to evaluate the genotype frequencies in studied population, and to find carriers of the rare genetic single nucleotide polymorphisms (SNPs), who will fulfill all the other inclusion criteria. An oral glucose tolerance test (OGTT) will be completed at screening visit. Moreover, the fasting blood samples will be collected for genetic analysis, and measurements of blood glucose and lipid metabolism profile, high-sensitivity C-reactive protein (hs-CRP), hormones/peptides and other factors involved in energy balance regulation. Subjects will be asked to record their daily food intake for 3 days. Assessments of vital signs and body height and weight, waist and hip circumferences, body fat content and body fat distribution, review of concomitant medication/supplement use and inclusion and exclusion criteria, and evaluation of adverse effects will be performed throughout the study. To meal challenge test only men will be included, since the sex hormones may influence the study endpoints. Subjects will be encouraged to maintain their habitual diet during wash-out periods. During the each meal challenge test subjects will consume one of the study meals in random order. The blood will be collected at fasting state and 30, 60, 120, 180 and 240 minutes after meal intake. The energy expenditure and substrate utilization will be measured by indirect calorimetry method at the fasting and postprandially.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
150
Subjects are going to receive the normo-carbohydrate meal.
Subjects are going to receive the high-carbohydrate meal.
Subjects are going to receive the high-fat meal.
Clinical Research Centre, Medical University of Bialystok
Bialystok, Polska, Poland
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Subjects are going to receive the high-protein meal.
Time frame: 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.
Time frame: Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.
The change and differences in postprandial ghrelin concentrations associated with investigated single nucleotide polymorphisms.
The postprandial change and differences in blood ghrelin concentrations (pg/mL) will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
Time frame: 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.
The postprandial change and differences in blood leptin concentrations (ng/mL) will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
Time frame: 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.
The postprandial change and differences in blood adiponectin concentrations (ng/mL) will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
Time frame: 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.
The postprandial change and differences in blood PYY (pg/mL) concentrations will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
Time frame: 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.
The postprandial change and differences in plasma metabolites profiles (metabolomic fingerprinting) will be evaluated dependently on the meal type, genetic and metabolic (body weight, body fat content) factors.
Time frame: Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.