NCT02381119

Effects of Personalized Dietary Advice on Health Status of Diabetes Type 2 Patients

The Personalized Dietary Advice Services: Effects of Use by the Dietician on Health Status of Diabetes Type 2 Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: TNO · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study addresses the challenge of increasing compliance with dietary recommendations and guidelines among diabetes type 2 patients by introducing professional dietary advice based on individual requirements. The objective of this study is to assess the effect of the Personalized Dietary Advice Services (PDAS) after a three month intervention on established markers of nutritional and health status in diabetes type 2 patients (HbA1c, glucose, insulin). Besides, the effect of the PDAS on perceived health status of diabetes type 2 patients will be assessed.

Detailed description

This study will be a randomized control trial studying the effect of personalized dietary advice services on established markers of nutrition and health status of diabetes type 2 patients. This dietary advice will be based on individual genetic, blood and food intake profiles, which will be measured at the start of the study. The dietitian will provide this personalized dietary advice, during the regular patient visits. In the control group, the dietitian will give the regular dietary advice. The study will start with a run-in period of two weeks, during which baseline measures will be done. After the run-in period, the three-month study will start with a first dietary consult during which the dietitian will use the personalized dietary advice services for providing dietary advice in the experimental group.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BEHAVIORAL	Personalized Dietary Advice Services	This Personalized Dietary Advice is based on markers for nutrition status and SNPs (single nucleotide polymorphisms). This advice is given via Personalized Dietary Advice Services, in which health data of the client can be entered and will be translated into advice on intake of specific nutrients or food categories.
BEHAVIORAL	Regular care	The control group will receive usual advice for diabetes type 2 from the dietician. However, after the end of the study participants in the control group will be offered the opportunity to receive the Personalized Dietary Advice from their dietician, as based on the parameters measured during the study.

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2015-03-06
• Last updated: 2016-01-12

Locations

8 sites across 1 country: Netherlands