Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

17. února 2021 aktualizováno: Medical University of Bialystok

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

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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

150

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Polska
      • Bialystok, Polska, Polsko, 15-276
        • Clinical Research Centre, Medical University of Bialystok

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Mužský

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Normal weight
Normal weight men. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, 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.
Experimentální: Overweight/obesity
Men with overweight or obesity. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, 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.
Experimentální: 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.
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The postprandial change and differences in blood glucose levels associated with investigated single nucleotide polymorphisms.
Časové okno: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
Časové okno: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
Časové okno: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
Časové okno: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
Časové okno: Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.
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.
Časové okno: Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.
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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The change and differences in postprandial ghrelin concentrations associated with investigated single nucleotide polymorphisms.
Časové okno: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
Časové okno: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
Časové okno: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
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.
Časové okno: Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.
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.
Časové okno: Fasting (time 0) and 30, 60, 120, 180 minutes after meal intake.
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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Ředitel studie: Edyta Adamska-Patruno, PhD, Clinical Research Centre, Medical University of Bialystok
  • Vrchní vyšetřovatel: Maria Gorska, Prof., Dept of Endocrinology, Diabetology and Internal Medicine
  • Vrchní vyšetřovatel: Adam Kretowski, Prof., Dept of Endocrinology, Diabetology and Internal Medicine; Clinical Research Centre

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

24. září 2009

Primární dokončení (Aktuální)

1. června 2020

Dokončení studie (Aktuální)

1. ledna 2021

Termíny zápisu do studia

První předloženo

26. prosince 2018

První předloženo, které splnilo kritéria kontroly kvality

1. ledna 2019

První zveřejněno (Aktuální)

3. ledna 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. února 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. února 2021

Naposledy ověřeno

1. února 2021

Více informací

Termíny související s touto studií

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit