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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Personalized Dietary Advice Services
* Behavioral: Regular care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized advice<br>Dietitian provides Personalized dietary advice (based on genetic, blood and food intake profiles) (the type of advice is the intervention) | Behavioral: Personalized Dietary Advice Services<br>* 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.<br>* Other names: Dietary advice based on individual health status;|
| Active Comparator: Regular care<br>Dietitian provides regular care for diabetes type 2 (regular advice is the control condition) | Behavioral: Regular care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| change in HbA1c levels | representing change in long-term blood glucose levels | 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) | week -2 (run-in period) and week 13 (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| change in subjective quality of life as assessed with RAND-36 questionnaire |  | week 0 (baseline) and week 13 (end of study) | 
| change in vitality as assessed with a vitality questionnaire (Vita-16) |  | week 0 (baseline) and week 13 (end of study) | 
| change in physical activity as assessed with a physical activity questionnaire |  | week 0 (baseline) and week 13 (end of study) | 
| user experiences with personalized dietary advice services as assessed with a questionnaire |  | week 13 (end of study) | 
| 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) | 
| change in biomarkers for food intake | change in blood levels representing food intake | week -2 (run-in period) and week 13 (end of study) | 
| change in levels of non-esterified fatty acids in blood |  | week -2 (run-in period) and week 13 (end of study) | 
| 20 nutrition-related SNPs (single nucleotide polymorphisms) | Genetic state | week -2 (run-in period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary services, personalized advice, biological markers