Status:

COMPLETED

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

Lead Sponsor:

Medical University of Bialystok

Collaborating Sponsors:

Ministry of Science and Higher Education, Poland

Conditions:

Overweight and Obesity

Diabetes Mellitus, Type 2

Eligibility:

MALE

18-65 years

Phase:

NA

Brief 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, ...

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 fe...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 24 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2021

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT03792685

Start Date

September 24 2009

End Date

January 1 2021

Last Update

February 21 2021

Active Locations (1)

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Clinical Research Centre, Medical University of Bialystok

Bialystok, Polska, Poland, 15-276