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

NCT02381119 | Completed

• 1 other identifier: P9618
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 8

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

dietary services; personalized advice; biological markers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• change in body weight

  week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)

• change in waist-to-hip ratio

  week -2 (run-in period), week 0, week 4, week 8 and week 13 (end of study)

• change in blood pressure

  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)

Study Arms (2)

Personalized advice

EXPERIMENTAL

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

Regular care

ACTIVE COMPARATOR

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

Behavioral: Regular care

Interventions

Personalized Dietary Advice Services 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.

Also known as: Algorithms for personalized dietary advice, Food4Me algorithms, Dietary advice based on individual health status

Personalized advice

Regular care 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.

Regular care

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TNO: lead
• Vitas: collaborator
• SwissAnalysis: collaborator

Study Sites (8)

Diëtistenpraktijk Sylvia van Daalen

Arnhem, Gelderland, 6825 AN, Netherlands

Location

Diëtistenpraktijk Verhoeven & Bac

Barendrecht, South Holland, Netherlands

Location

independent practice Willy Gilbert

Dordrecht, South Holland, Netherlands

Location

Diëtistenpraktijk Jansen-Sloot

Gorinchem, South Holland, Netherlands

Location

Diëtistenpraktijk Care & Cure

Hillegom, South Holland, 2182 CA, Netherlands

Location

Diëtistenpraktijk MirjaM - Leefstijl & Dieet

Sassenheim, South Holland, 2172 HC, Netherlands

Location

Diëtistenpraktijk Dieetistopsport

Zoetermeer, South Holland, 2717 TK, Netherlands

Location

Netherlands Organisation for Applied Scientific Research (TNO)

Zeist, Utrecht, 3704 HE, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader Clinical studies

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 6, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

NL (8)