Diabetes type 2
Conditions
Interventions
The intervention in this study consists of personalized dietary advice given by
the dietician. This Personalized Dietary Advice is based on markers for
nutrition status and SNPs.
This advice is giv
biological markers
diabetes mellitus
dietary services
personalized advice
Sponsors
TNO
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age 30-80 years; 2. Stable BMI 25-35 kg/m2 3. Diabetes type 2 as diagnosed by the 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 4. Healthy as assessed by the health and lifestyle questionnaire (P9607 F02; in Dutch); 5. Voluntary participation; 6. Informed consent signed; 7. Willing to comply with the study procedures; 8. Willingness to share pseudonymized data on food intake with external party MijnEetmeter (food intake app provider) 9. Willingness to share pseudonymized data on physical activity with external party Medisana (provider of activity tracker) 10. 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 11. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for 15 years. 12. Have a desktop or laptop with internet access at home.
Exclusion criteria
Exclusion criteria: 1. 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; 2. Use of insulin or Sulfonyl Urea derivatives; 3. Slow onset type 1 diabetes; 4. Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes; 5. (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; 6. Following a medically prescribed diet, other than dietary advice for diabetes type 2; 7. Use of nutritional supplements that could influence the study outcome, including vitamin supplements, fish oil and/or omega fatty acids; 8. Physical, mental or practical limitations in using computers; 9. Alcohol consumption > 21 (women) - 28 (men) units/week; 10. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening; 11. Recent blood donation (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters will be fasting plasma glucose (FPG), HbA1c and fasting insulin. These variables will be measured at the beginning of the run-in week (week -2) and at the end of the intervention (week 13) and will be compared with the control group. By comparing the effects of the intervention to data from a control group receiving regular care, the added value of the Personalized Dietary Advice Services for participants can be estimated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives in the study are the effects of the intervention on other physical and clinical parameters (body weight (BW), waist circumference (WC), hip circumference (HC), waist-to-hip-ratio (WHR), body mass index (BMI), blood pressure (BP), non-esterified fatty acids (NEFA), and biomarkers for food intake (cholesterol, plasma carotenoids, plasma fatty acids, plasma vitamins, omega 3 index, SNPs). In figure 8, all measured biomarkers for food intake are listed. Also, changes in physical activity (activity tracker and IPAQ questionnaire) and food intake (online food diary and food frequency questionnaire via the OPEN platform) from baseline to end of study are determined and compared with the control group. The subjects will fill out online-questionnaires on vitality (Vita-16) and quality of life (RAND-36) at baseline and at the end of the study. Finally, both dieticians and subjects will fill out an online-questionnaires on user experiences at the end of the study. | — |
Countries
The Netherlands
Outcome results
None listed