NCT05666843

Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes

The Effects of Personalized Dietary Guidance to Increase the Intake of Fibre-rich Foods on Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes. (in Dutch: Voed je Beter Met Diabetes Type 2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Wageningen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Previous interventions with fibre supplements show promising results among individuals with type 2 diabetes, but wether these effects are similar when higher fiber intake is achieved through diet and not through supplements remains unclear. The primary objective of this study is to investigate the effects of personalized dietary guidance to increase the intake of fibre-rich foods, as recommended in the Dutch dietary guidelines, on cardiometabolic risk profile in individuals who have type 2 diabetes, compared to usual care after six months. The study is a parallel randomized trial over a period of twelve months, including an intervention period of six months and a follow up period of six months. The study population consists of adults with non-insulin-dependent type 2 diabetes, diagnosed by a medical doctor at least 6 months prior to study enrolment.

Conditions

• Diabetes Mellitus, Type 2
• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Personalized Dietary Advice	Personalized dietary guidance to increase the intake of fibre-rich foods on top of usual care.The dietary guidance is implemented by dieticians and is personalized based on current adherence to the dietary guidelines, usual dietary intake, gender and personal goals and preferences.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-07-31
• Completion: 2024-12-31
• First posted: 2022-12-28
• Last updated: 2025-03-26

Locations

1 site across 1 country: Netherlands