NCT03792685

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

Completed NA Last updated 21 February 2021

What this trial tests

NA trial testing Normo-carbohydrate meal intake in Overweight and Obesity in 150 participants. Completed in 1 January 2021.

Timeline

24 September 2009

Primary endpoint
1 June 2020

1 January 2021

Quick facts

Lead sponsor	Medical University of Bialystok
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	150
Start date	24 September 2009
Primary completion	1 June 2020
Estimated completion	1 January 2021
Sites	1 location across Poland

Drugs / interventions tested

• Normo-carbohydrate meal intake
• High-carbohydrate meal intake
• High-fat meal intake
• High-protein meal intake

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Genetic Predisposition — all drugs for Genetic Predisposition →

Sponsor

Medical University of Bialystok

Who can join

Adults 18 to 65, male only, with Overweight and Obesity or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Impact of <i>FTO</i> Genetic Variants on Obesity and Its Metabolic Consequences is Dependent on Daily Macronutrient Intake.
   Czajkowski P, Adamska-Patruno E, Bauer W, Fiedorczuk J, et al · · 2020 · cited 30× · PMID 33114268 · DOI 10.3390/nu12113255
2. The MC4R genetic variants are associated with lower visceral fat accumulation and higher postprandial relative increase in carbohydrate utilization in humans.
   Adamska-Patruno E, Goscik J, Czajkowski P, Maliszewska K, et al · · 2019 · cited 23× · PMID 30945034 · DOI 10.1007/s00394-019-01955-0
3. Evaluation of Transcriptomic Regulations behind Metabolic Syndrome in Obese and Lean Subjects.
   Paczkowska-Abdulsalam M, Niemira M, Bielska A, Szałkowska A, et al · · 2020 · cited 17× · PMID 32093387 · DOI 10.3390/ijms21041455
4. The Type 2 Diabetes Susceptibility PROX1 Gene Variants Are Associated with Postprandial Plasma Metabolites Profile in Non-Diabetic Men.
   Adamska-Patruno E, Godzien J, Ciborowski M, Samczuk P, et al · · 2019 · cited 17× · PMID 31010169 · DOI 10.3390/nu11040882
5. Metabolomics Reveal Altered Postprandial Lipid Metabolism After a High-Carbohydrate Meal in Men at High Genetic Risk of Diabetes.
   Adamska-Patruno E, Samczuk P, Ciborowski M, Godzien J, et al · · 2019 · cited 14× · PMID 31049566 · DOI 10.1093/jn/nxz024
6. An Association between Diet and <i>MC4R</i> Genetic Polymorphism, in Relation to Obesity and Metabolic Parameters-A Cross Sectional Population-Based Study.
   Adamska-Patruno E, Bauer W, Bielska D, Fiedorczuk J, et al · · 2021 · cited 13× · PMID 34769477 · DOI 10.3390/ijms222112044
7. Dietary Macronutrient Intake May Influence the Effects of TCF7L2 rs7901695 Genetic Variants on Glucose Homeostasis and Obesity-Related Parameters: A Cross-Sectional Population-Based Study.
   Bauer W, Adamska-Patruno E, Krasowska U, Moroz M, et al · · 2021 · cited 11× · PMID 34200102 · DOI 10.3390/nu13061936
8. Dietary Fiber Intake May Influence the Impact of <i>FTO</i> Genetic Variants on Obesity Parameters and Lipid Profile-A Cohort Study of a Caucasian Population of Polish Origin.
   Czajkowski P, Adamska-Patruno E, Bauer W, Krasowska U, et al · · 2021 · cited 10× · PMID 34829664 · DOI 10.3390/antiox10111793