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

NCT ID: NCT02381119

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized advice

Dietitian provides Personalized dietary advice (based on genetic, blood and food intake profiles) (the type of advice is the intervention)

Group Type: EXPERIMENTAL

Personalized Dietary Advice Services

Intervention Type: BEHAVIORAL

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

Dietitian provides regular care for diabetes type 2 (regular advice is the control condition)

Group Type: ACTIVE_COMPARATOR

Regular care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Algorithms for personalized dietary advice; Food4Me algorithms; Dietary advice based on individual health status

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitas

UNKNOWN

Sponsor Role: collaborator

SwissAnalysis

UNKNOWN

Sponsor Role: collaborator

TNO

OTHER

Sponsor Role: lead

Responsible Party

W.J. Pasman

Project leader Clinical studies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Diëtistenpraktijk Sylvia van Daalen

Arnhem, Gelderland, Netherlands

Diëtistenpraktijk Verhoeven & Bac

Barendrecht, South Holland, Netherlands

independent practice Willy Gilbert

Dordrecht, South Holland, Netherlands

Diëtistenpraktijk Jansen-Sloot

Gorinchem, South Holland, Netherlands

Diëtistenpraktijk Care & Cure

Hillegom, South Holland, Netherlands

Diëtistenpraktijk MirjaM - Leefstijl & Dieet

Sassenheim, South Holland, Netherlands

Diëtistenpraktijk Dieetistopsport

Zoetermeer, South Holland, Netherlands

Netherlands Organisation for Applied Scientific Research (TNO)

Zeist, Utrecht, Netherlands

Countries

Netherlands

Other Identifiers

P9618

Identifier Type: -

Identifier Source: org_study_id