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

Medical University of Bialystok

Status: Completed

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

Treatments: Other: High-protein meal intake; Other: High-carbohydrate meal intake; Other: High-fat meal intake; Other: Normo-carbohydrate meal intake

Study type: Interventional

Funder types: Other

Identifiers

NCT03792685

N N402 477437

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Normal weight

Experimental group

Description:

Normal weight men. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.

Treatment:

Other: High-protein meal intake

Other: Normo-carbohydrate meal intake

Other: High-fat meal intake

Other: High-carbohydrate meal intake

Overweight/obesity

Experimental group

Description:

Men with overweight or obesity. Interventions: normo-carbohydrate meal intake, high-carbohydrate meal intake, high-fat meal intake, high-protein meal intake.

Treatment:

Other: High-protein meal intake

Other: Normo-carbohydrate meal intake

Other: High-fat meal intake

Other: High-carbohydrate meal intake

Diabetes

Experimental group

Description:

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.

Treatment:

Other: High-protein meal intake

Other: Normo-carbohydrate meal intake

Other: High-fat meal intake

Other: High-carbohydrate meal intake