Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes (NCT05666843) | Clinical Trial Compass
CompletedNot Applicable
Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes
Netherlands124 participantsStarted 2022-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of type 2 diabetes made by a medical doctor at least 6 months prior to study enrolment
* Adult
* Willing and able to follow dietary intervention
* Willing to participate in both intervention and control group
* Living 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 therapy
* Recently (\< 6 months) or currently being under supervision of a dietician
* Pregnant or breast-feeding
* History of bariatric surgery, including gastric banding
* Current participation in a study with an investigational drug or dietary intervention
* Excessive alcohol consumption (more than 14 units for males/7 units for females per week) or drug use
* Clinical 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 language
* No general practitioner
* Working at the department of Human Nutrition and Health at Wageningen University \& Research