An interventional study of Normo-carbohydrate meal intake and High-carbohydrate meal intake in Overweight and Obesity, Diabetes Mellitus, Type 2 and Metabolic Syndrome, sponsored by Medical University of Bialystok. Completed at 1 site in Poland. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Medical University of Bialystok · Not applicable, Interventional, and Basic science
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 150 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Medical University of Bialystok is the lead sponsor of 68 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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.
Subjects are going to receive the high-protein meal.
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.
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.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Bialystok