NCT03792685

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Medical University of Bialystok · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Normo-carbohydrate meal intake	Subjects are going to receive the normo-carbohydrate meal.
OTHER	High-carbohydrate meal intake	Subjects are going to receive the high-carbohydrate meal.
OTHER	High-fat meal intake	Subjects are going to receive the high-fat meal.
OTHER	High-protein meal intake	Subjects are going to receive the high-protein meal.

Timeline

• Start date: 2009-09-24
• Primary completion: 2020-06-01
• Completion: 2021-01-01
• First posted: 2019-01-03
• Last updated: 2021-02-21

Locations

1 site across 1 country: Poland