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

Diabetes Mellitus, Type 2 Clinical Trial

— PDA(4)T2D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381119
• Other study ID #: P9618
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: January 10, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 30-80 years;

• Stable BMI 25-35 kg/m2

• Diabetes type 2 as diagnosed by the General Practitioner (GP), based upon:

• Fasting glucose > 6.9 mmol/l on two different days or one measurement of non-fasting glucose > 11.0 mmol/l in combination with symptoms of hyperglycemia

• Healthy as assessed by the health and lifestyle questionnaire (P9607 F02; in Dutch);

• Voluntary participation;

• Informed consent signed;

• Willing to comply with the study procedures;

• Willingness to share pseudonymized data on food intake with external party MijnEetmeter (food intake app provider)

• Willingness to share pseudonymized data on physical activity with external party Medisana (provider of activity tracker)

• Willingness to share pseudonymized data on food intake, blood glucose, blood cholesterol, blood pressure, physical activity and body weight with the Nutrition Research Cohort (NRC) database

• Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for 15 years.

• Have a desktop or laptop with internet access at home.

Exclusion Criteria:

• Use of concomitant medication including medication known for its effects the main study parameters, except for medication for diabetes type 2, cholesterol or blood pressure;

• Use of insulin or Sulfonyl Urea derivatives;

• Slow onset type 1 diabetes;

• Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes;

• (Having a history of a) medical condition that might significantly affect the study outcome as judged by the medical investigator and health and life style questionnaire. This includes diabetes type 1, gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder;

• Following a medically prescribed diet, other than dietary advice for diabetes type 2;

• Use of nutritional supplements that could influence the study outcome, including vitamin supplements, fish oil and/or omega fatty acids;

• Physical, mental or practical limitations in using computers;

• Alcohol consumption > 21 (women) - 28 (men) units/week;

• Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening;

• Recent blood donation (< 1 month prior to the start of the study);

• Not willing to give up blood donation during the study;

• Not having a general practitioner;

• Personnel of TNO in Zeist and Soesterberg and their partners.

• Not willing to accept information-transfer concerning study participation, or health-related information, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from the participant's general practitioner.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Diëtistenpraktijk Sylvia van Daalen	Arnhem	Gelderland
Netherlands	Diëtistenpraktijk Verhoeven & Bac	Barendrecht	Zuid-Holland
Netherlands	independent practice Willy Gilbert	Dordrecht	Zuid-Holland
Netherlands	Diëtistenpraktijk Jansen-Sloot	Gorinchem	Zuid-Holland
Netherlands	Diëtistenpraktijk Care & Cure	Hillegom	Zuid-Holland
Netherlands	Diëtistenpraktijk MirjaM - Leefstijl & Dieet	Sassenheim	Zuid-Holland
Netherlands	Netherlands Organisation for Applied Scientific Research (TNO)	Zeist	Utrecht
Netherlands	Diëtistenpraktijk Dieetistopsport	Zoetermeer	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
TNO	SwissAnalysis, Vitas

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in fasting plasma glucose	blood glucose levels after an overnight fast (not eating or drinking for at least 8 hours)	week -2 (run-in period) and week 13 (end of study)	No
Primary	change in HbA1c levels	representing change in long-term blood glucose levels	week -2 (run-in period) and week 13 (end of study)	No
Primary	change in fasting insulin levels	blood insulin levels after an overnight fast (not eating or drinking for at least 8 hours)	week -2 (run-in period) and week 13 (end of study)	No
Secondary	change in body weight	also used for calculation of body mass index (BMI)	week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)	No
Secondary	change in waist-to-hip ratio	ratio between waist and hip circumference as measured by the dietitian	week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)	No
Secondary	change in blood pressure	as measured by the dietitian	week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)	No
Secondary	change in subjective quality of life as assessed with RAND-36 questionnaire		week 0 (baseline) and week 13 (end of study)	No
Secondary	change in vitality as assessed with a vitality questionnaire (Vita-16)		week 0 (baseline) and week 13 (end of study)	No
Secondary	change in physical activity as assessed with a physical activity questionnaire		week 0 (baseline) and week 13 (end of study)	No
Secondary	user experiences with personalized dietary advice services as assessed with a questionnaire		week 13 (end of study)	No
Secondary	change in blood cholesterol levels	change in total cholesterol as well as HDL, LDL and triglyceride levels	week 0 (baseline), week 4, week 8 and week 13 (end of study)	No
Secondary	change in biomarkers for food intake	change in blood levels representing food intake	week -2 (run-in period) and week 13 (end of study)	No
Secondary	change in levels of non-esterified fatty acids in blood		week -2 (run-in period) and week 13 (end of study)	No
Secondary	20 nutrition-related SNPs (single nucleotide polymorphisms)	Genetic state	week -2 (run-in period)	No