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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Analysis of Genetic Aspects of Metabolic Response on Diet With Different Content of Carbohydrate and Fat. Searching for Genetic Markers for Individualized Therapy in Patients With Obesity and Type 2 Diabetes

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

Intervention / Treatment
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* Other: Normo-carbohydrate meal intake
* Other: High-carbohydrate meal intake
* Other: High-fat meal intake
* Other: High-protein meal intake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal weight<br>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<br>* Subjects are going to receive the normo-carbohydrate meal.<br>Other: High-carbohydrate meal intake<br>* Subjects are going to receive the high-carbohydrate meal.<br>Other: High-fat meal intake<br>* Subjects are going to receive the high-fat meal.<br>Other: High-protein meal intake<br>* Subjects are going to receive the high-protein meal.<br>|
| Experimental: Overweight/obesity<br>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<br>* Subjects are going to receive the normo-carbohydrate meal.<br>Other: High-carbohydrate meal intake<br>* Subjects are going to receive the high-carbohydrate meal.<br>Other: High-fat meal intake<br>* Subjects are going to receive the high-fat meal.<br>Other: High-protein meal intake<br>* Subjects are going to receive the high-protein meal.<br>|
| Experimental: Diabetes<br>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<br>* Subjects are going to receive the normo-carbohydrate meal.<br>Other: High-carbohydrate meal intake<br>* Subjects are going to receive the high-carbohydrate meal.<br>Other: High-fat meal intake<br>* Subjects are going to receive the high-fat meal.<br>Other: High-protein meal intake<br>* Subjects are going to receive the high-protein meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake. |