Effects of Personalized Dietary Advice on Health Status of Diabetes Type 2 Patients (PDA(4)T2D)

Netherlands Organisation for Applied Scientific Research (TNO)

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: Regular care

Behavioral: Personalized Dietary Advice Services

Study type

Interventional

Funder types

Other

Identifiers

NCT02381119

P9618

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.