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Recruiting
NCT05666843
Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes
Conditions: Diabetes Mellitus, Type 2, Cardiovascular Diseases
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 156
Sponsor: Wageningen University
Location: Netherlands
Summary
This is a randomized controlled trial to examine whether personalized guidance to increase the consumption of fiber rich food items according to the Dutch dietary guidelines, compared to usual care, improves health of individuals with type 2 diabetes.
Eligibility Criteria
Inclusion Criteria:Diagnosis of type 2 diabetes made by a medical doctor at least 6 months prior to study enrolmentAdultWilling and able to follow dietary interventionWilling to participate in both intervention and control groupLiving at a reasonable distance from the research center at Wageningen University & Research (WUR) (i.e.maximum of ± 1 hour away)Exclusion Criteria:Currently treated with insulin therapyRecently (< 6 months) or currently being under supervision of a dieticianPregnant or breast-feedingHistory of bariatric surgery, including gastric bandingCurrent participation in a study with an investigational drug or dietary interventionExcessive alcohol consumption (more than 14 units for males/7 units for females per week) or drug useClinical disorders that could interfere with the intervention (e.g.
gastro-intestinal disorders, auto-immune diseases, psychiatric disorders, uncontrolled heart diseases, serious neurological disorders, renal failure or cancer)Not able to speak and understand the Dutch languageNo general practitionerWorking at the department of Human Nutrition and Health at Wageningen University & Research
Source: ClinicalTrials.gov (NCT05666843). StuddyBuddy aggregates publicly available trial information.