Clinical trial NCT02381119: Effects of Personalized Dietary Advice on Health Status of Diabetes Type 2 Patients
Official title: The Personalized Dietary Advice Services: Effects of Use by the Dietician on Health Status of Diabetes Type 2 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: dietary services
personalized advice
biological markers
Lead sponsor: TNO
Sponsor class: OTHER
Collaborators: name: Vitas
name: SwissAnalysis
First posted: 2015-03-06
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in fasting plasma glucose
timeFrame: week -2 (run-in period) and week 13 (end of study)
measure: change in HbA1c levels
timeFrame: week -2 (run-in period) and week 13 (end of study)
measure: change in fasting insulin levels
timeFrame: week -2 (run-in period) and week 13 (end of study)
Secondary outcomes:
measure: change in body weight
timeFrame: week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
measure: change in waist-to-hip ratio
timeFrame: week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
measure: change in blood pressure
timeFrame: week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
measure: change in subjective quality of life as assessed with RAND-36 questionnaire
timeFrame: week 0 (baseline) and week 13 (end of study)
measure: change in vitality as assessed with a vitality questionnaire (Vita-16)
timeFrame: week 0 (baseline) and week 13 (end of study)
measure: change in physical activity as assessed with a physical activity questionnaire
timeFrame: week 0 (baseline) and week 13 (end of study)
measure: user experiences with personalized dietary advice services as assessed with a questionnaire
timeFrame: week 13 (end of study)
measure: change in blood cholesterol levels
timeFrame: week 0 (baseline), week 4, week 8 and week 13 (end of study)
measure: change in biomarkers for food intake
timeFrame: week -2 (run-in period) and week 13 (end of study)
measure: change in levels of non-esterified fatty acids in blood
timeFrame: week -2 (run-in period) and week 13 (end of study)
measure: 20 nutrition-related SNPs (single nucleotide polymorphisms)
timeFrame: week -2 (run-in period)
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Diëtistenpraktijk Sylvia van Daalen
state: Gelderland
city: Zeist
country: Netherlands
facility: Netherlands Organisation for Applied Scientific Research (TNO)
state: Utrecht
city: Barendrecht
country: Netherlands
facility: Diëtistenpraktijk Verhoeven & Bac
state: Zuid-Holland
city: Dordrecht
country: Netherlands
facility: independent practice Willy Gilbert
state: Zuid-Holland
city: Gorinchem
country: Netherlands
facility: Diëtistenpraktijk Jansen-Sloot
state: Zuid-Holland
city: Hillegom
country: Netherlands
facility: Diëtistenpraktijk Care & Cure
state: Zuid-Holland
city: Sassenheim
country: Netherlands
facility: Diëtistenpraktijk MirjaM - Leefstijl & Dieet
state: Zuid-Holland
city: Zoetermeer
country: Netherlands
facility: Diëtistenpraktijk Dieetistopsport
state: Zuid-Holland
Study officials:
References: