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

17. Februar 2021 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

150

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Männlich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Experimental: 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.
Experimental: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The postprandial change and differences in blood glucose levels associated with investigated single nucleotide polymorphisms.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The change and differences in postprandial ghrelin concentrations associated with investigated single nucleotide polymorphisms.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. September 2009

Primärer Abschluss (Tatsächlich)

1. Juni 2020

Studienabschluss (Tatsächlich)

1. Januar 2021

Studienanmeldedaten

Zuerst eingereicht

26. Dezember 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Januar 2019

Zuerst gepostet (Tatsächlich)

3. Januar 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. Februar 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Februar 2021

Zuletzt verifiziert

1. Februar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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