- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02381119
Effects of Personalized Dietary Advice on Health Status of Diabetes Type 2 Patients (PDA(4)T2D)
The Personalized Dietary Advice Services: Effects of Use by the Dietician on Health Status of Diabetes Type 2 Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gelderland
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Arnhem, Gelderland, Netherlands, 6825 AN
- Diëtistenpraktijk Sylvia van Daalen
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Utrecht
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Zeist, Utrecht, Netherlands, 3704 HE
- Netherlands Organisation for Applied Scientific Research (TNO)
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Zuid-Holland
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Barendrecht, Zuid-Holland, Netherlands
- Diëtistenpraktijk Verhoeven & Bac
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Dordrecht, Zuid-Holland, Netherlands
- independent practice Willy Gilbert
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Gorinchem, Zuid-Holland, Netherlands
- Diëtistenpraktijk Jansen-Sloot
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Hillegom, Zuid-Holland, Netherlands, 2182 CA
- Diëtistenpraktijk Care & Cure
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Sassenheim, Zuid-Holland, Netherlands, 2172 HC
- Diëtistenpraktijk MirjaM - Leefstijl & Dieet
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Zoetermeer, Zuid-Holland, Netherlands, 2717 TK
- Diëtistenpraktijk Dieetistopsport
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Personalized advice
Dietitian provides Personalized dietary advice (based on genetic, blood and food intake profiles) (the type of advice is the intervention)
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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.
Other Names:
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Active Comparator: Regular care
Dietitian provides regular care for diabetes type 2 (regular advice is the control condition)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in fasting plasma glucose
Time Frame: week -2 (run-in period) and week 13 (end of study)
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blood glucose levels after an overnight fast (not eating or drinking for at least 8 hours)
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week -2 (run-in period) and week 13 (end of study)
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change in HbA1c levels
Time Frame: week -2 (run-in period) and week 13 (end of study)
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representing change in long-term blood glucose levels
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week -2 (run-in period) and week 13 (end of study)
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change in fasting insulin levels
Time Frame: week -2 (run-in period) and week 13 (end of study)
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blood insulin levels after an overnight fast (not eating or drinking for at least 8 hours)
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week -2 (run-in period) and week 13 (end of study)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in body weight
Time Frame: week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
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also used for calculation of body mass index (BMI)
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week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
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change in waist-to-hip ratio
Time Frame: week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
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ratio between waist and hip circumference as measured by the dietitian
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week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
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change in blood pressure
Time Frame: week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
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as measured by the dietitian
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week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)
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change in subjective quality of life as assessed with RAND-36 questionnaire
Time Frame: week 0 (baseline) and week 13 (end of study)
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week 0 (baseline) and week 13 (end of study)
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change in vitality as assessed with a vitality questionnaire (Vita-16)
Time Frame: week 0 (baseline) and week 13 (end of study)
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week 0 (baseline) and week 13 (end of study)
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change in physical activity as assessed with a physical activity questionnaire
Time Frame: week 0 (baseline) and week 13 (end of study)
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week 0 (baseline) and week 13 (end of study)
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user experiences with personalized dietary advice services as assessed with a questionnaire
Time Frame: week 13 (end of study)
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week 13 (end of study)
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change in blood cholesterol levels
Time Frame: week 0 (baseline), week 4, week 8 and week 13 (end of study)
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change in total cholesterol as well as HDL, LDL and triglyceride levels
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week 0 (baseline), week 4, week 8 and week 13 (end of study)
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change in biomarkers for food intake
Time Frame: week -2 (run-in period) and week 13 (end of study)
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change in blood levels representing food intake
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week -2 (run-in period) and week 13 (end of study)
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change in levels of non-esterified fatty acids in blood
Time Frame: week -2 (run-in period) and week 13 (end of study)
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week -2 (run-in period) and week 13 (end of study)
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20 nutrition-related SNPs (single nucleotide polymorphisms)
Time Frame: week -2 (run-in period)
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Genetic state
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week -2 (run-in period)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P9618
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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