Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Dyslipidemia
  • Hypertension
  • Metabolic Syndrome
  • NAFLD
  • Obesity
  • Type 2 Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 79 years
Gender
Both males and females

Description

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. The resear...

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere). POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors for the maintenance period within DiNA-D (11 months) will be PUFAs and BCAAs, provided by walnuts and custom-made muffins containing walnuts, sunflower oil and isomaltulose.

Tracking Information

NCT #
NCT03047668
Collaborators
  • German Center for Diabetes Research
  • California Walnut Commission
  • Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
Investigators
Principal Investigator: Andreas FH Pfeiffer, Prof. Dr. med. DIfE