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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
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.
Diëtistenpraktijk Sylvia van Daalen
Arnhem, Gelderland, Netherlands
Diëtistenpraktijk Verhoeven & Bac
Barendrecht, South Holland, Netherlands
independent practice Willy Gilbert
Dordrecht, South Holland, Netherlands
Diëtistenpraktijk Jansen-Sloot
change in fasting plasma glucose
blood glucose levels after an overnight fast (not eating or drinking for at least 8 hours)
Time frame: week -2 (run-in period) and week 13 (end of study)
change in HbA1c levels
representing change in long-term blood glucose levels
Time frame: week -2 (run-in period) and week 13 (end of study)
change in fasting insulin levels
blood insulin levels after an overnight fast (not eating or drinking for at least 8 hours)
Time frame: week -2 (run-in period) and week 13 (end of study)
change in body weight
also used for calculation of body mass index (BMI)
Time frame: week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
change in waist-to-hip ratio
ratio between waist and hip circumference as measured by the dietitian
Time frame: week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
change in blood pressure
as measured by the dietitian
Time frame: week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
change in subjective quality of life as assessed with RAND-36 questionnaire
Time frame: week 0 (baseline) and week 13 (end of study)
change in vitality as assessed with a vitality questionnaire (Vita-16)
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Gorinchem, South Holland, Netherlands
Diëtistenpraktijk Care & Cure
Hillegom, South Holland, Netherlands
Diëtistenpraktijk MirjaM - Leefstijl & Dieet
Sassenheim, South Holland, Netherlands
Diëtistenpraktijk Dieetistopsport
Zoetermeer, South Holland, Netherlands
Netherlands Organisation for Applied Scientific Research (TNO)
Zeist, Utrecht, Netherlands
Time frame: week 0 (baseline) and week 13 (end of study)
change in physical activity as assessed with a physical activity questionnaire
Time frame: week 0 (baseline) and week 13 (end of study)
user experiences with personalized dietary advice services as assessed with a questionnaire
Time frame: week 13 (end of study)
change in blood cholesterol levels
change in total cholesterol as well as HDL, LDL and triglyceride levels
Time frame: week 0 (baseline), week 4, week 8 and week 13 (end of study)
change in biomarkers for food intake
change in blood levels representing food intake
Time frame: week -2 (run-in period) and week 13 (end of study)
change in levels of non-esterified fatty acids in blood
Time frame: week -2 (run-in period) and week 13 (end of study)
20 nutrition-related SNPs (single nucleotide polymorphisms)
Genetic state
Time frame: week -2 (run-in period)