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Diabetes Mellitus, Type 2VJBD2NCT05666843

Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes

A study testing Personalized Dietary Advice in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Wageningen University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized controlled trial to examine whether personalized guidance to increase the consumption of fiber rich food items according to the Dutch dietary guidelines, compared to usual care, improves health of individuals with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Personalized Dietary Advice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteNetherlands
Study dates
1 Nov 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of type 2 diabetes made by a medical doctor at least 6 months prior to study enrolment
  • Adult
  • Willing and able to follow dietary intervention
  • Willing to participate in both intervention and control group
  • Living at a reasonable distance from the research center at Wageningen University \& Research (WUR) (i.e.maximum of ± 1 hour away)

Who cannot join

  • Currently treated with insulin therapy
  • Recently (< 6 months) or currently being under supervision of a dietician
  • Pregnant or breast-feeding
  • History of bariatric surgery, including gastric banding
  • Current participation in a study with an investigational drug or dietary intervention
  • Excessive alcohol consumption (more than 14 units for males/7 units for females per week) or drug use
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  • Clinical disorders that could interfere with the intervention (e.g. gastro-intestinal disorders, auto-immune diseases, psychiatric disorders, uncontrolled heart diseases, serious neurological disorders, renal failure or cancer)
  • Not able to speak and understand the Dutch language
  • No general practitioner
  • Working at the department of Human Nutrition and Health at Wageningen University \& Research

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Wageningen University and Research

    Wageningen, Gelderland, 6708WE

Other trials in Netherlands

About this study

Official title: The Effects of Personalized Dietary Guidance to Increase the Intake of Fibre-rich Foods on Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes. (in Dutch: Voed je Beter Met Diabetes Type 2)

This is a randomized controlled trial to examine whether personalized guidance to increase the consumption of fiber rich food items according to the Dutch dietary guidelines, compared to usual care, improves health of individuals with type 2 diabetes.

Read the detailed description

Previous interventions with fibre supplements show promising results among individuals with type 2 diabetes, but wether these effects are similar when higher fiber intake is achieved through diet and not through supplements remains unclear.

The primary objective of this study is to investigate the effects of personalized dietary guidance to increase the intake of fibre-rich foods, as recommended in the Dutch dietary guidelines, on cardiometabolic risk profile in individuals who have type 2 diabetes, compared to usual care after six months.

The study is a parallel randomized trial over a period of twelve months, including an intervention period of six months and a follow up period of six months. The study population consists of adults with non-insulin-dependent type 2 diabetes, diagnosed by a medical doctor at least 6 months prior to study enrolment.

Being tested
Personalized Dietary Advice
Keywords
dietary guidelines, dietitian, dietary fiber, diabetes type 2, nutrition, randomized controlled trial (RCT), cardiovascular diseases
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Dietary AdviceBehavioural

    Personalized dietary guidance to increase the intake of fibre-rich foods on top of usual care.The dietary guidance is implemented by dieticians and is personalized based on current adherence to the dietary guidelines, usual dietary intake, gender and personal goals and preferences.

Study groups in NCT05666843
Study groupRoleWhat they receive
Intervention groupExperimentalPersonalized dietary guidance to increase the intake of fibre-rich foods on top of usual care. The dietary guidance is implemented by dieticians and is personalized based on current adherence to the dietary guidelines, usual dietary intake, gender and personal goals and preferences.
Receives: Behavioral: Personalized Dietary Advice
Usual care groupNo interventionParticipants in the control group receive usual health care as provided by general practitioners and nurse practitioners or other health care professionals involved in diabetes care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiometabolic risk profile (DIAL risk score)

    The change in cardiovascular risk based on observed changes in HbA1c, LDL-cholesterol and systolic blood pressure. DIAL risk score ranges from 0 to 100%, with higher scores indicating a higher risk.

    Measured: Change from baseline at 6 months

Secondary outcomes (30)

  1. Cardiometabolic risk profile (DIAL risk score)

    The change in cardiovascular risk based on observed changes in HbA1c, LDL-cholesterol and systolic blood pressure. DIAL risk score ranges from 0 to 100%, with higher scores indicating a higher risk.

    Measured: Change from baseline at 12 months

  2. Body weight (in kilograms)

    As measured with a digital scale

    Measured: baseline, 6 months, 12 months

  3. Body mass index (kg/m^2)

    Weight and height will be combined to report BMI in kg/m^2.

    Measured: baseline, 6 months, 12 months

  4. Waist circumference

    in centimeters

    Measured: baseline, 6 months, 12 months

  5. Blood lipids

    Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides

    Measured: baseline, 6 months, 12 months

  6. Dietary intake

    Nutrient intake and diet quality score for the level of adherence to the Dutch dietary guidelines. Diet quality score (Dutch Healthy Diet index) ranges from 0-160, with higher scores indicating better diet quality.

    Measured: baseline, 3 months, 6 months, 12 months

  7. Micronutrient status

    Micronutrient status as measured with biomarkers in blood and (24-hour) urine samples

    Measured: baseline, 6 months, 12 months

  8. Food literacy

    Food literacy level by means of the 29-item Self Perceived Food Literacy Scale (SPFL-29). Scores range from 29-145, with higher scores indicating a higher level food literacy.

    Measured: baseline, 3 months, 6 months, 12 months

  9. HbA1c

    As determined in blood samples

    Measured: baseline, 6 months, 12 month

  10. Fasting glucose

    As determined in blood samples

    Measured: baseline, 6 months, 12 month

  11. Fasting insulin

    As determined in blood samples

    Measured: baseline, 6 months, 12 month

  12. C-peptide

    As determined in blood samples

    Measured: baseline, 6 months, 12 month

  13. Blood pressure

    Systolic and diastolic blood pressure (mmHg) as determined with a digital blood pressure monitor

    Measured: baseline, 6 months, 12 months

  14. Estimated Glomerular Filtration Rate (eGFR)

    in ml/min/1,73 m2 as determined from blood sample

    Measured: baseline, 6 months, 12 months

  15. Urinary albumin levels

    in grams per deciliter (g/dL) as determined from urine sample

    Measured: baseline, 6 months, 12 months

  16. Liver function

    Aspartate transaminase (AST) and Alanine transaminase (ALT) ratio as determined from blood sample

    Measured: baseline, 6 months, 12 months

  17. Inflammatory markers

    hsCRP in blood samples

    Measured: baseline, 6 months, 12 months

  18. Quality of life score

    Health related quality of life assessed with the 36-Item Short Form Survey (SF-36). Scores range from 0-100, with higher scores indicating higher quality of life.

    Measured: baseline, 3 months, 6 months, 12 months

  19. Health index score

    5-level EuroQol-5D version (EQ-5D). The maximum score of 1 indicates the best health state. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.

    Measured: baseline, 3 months, 6 months, 12 months

  20. Positive health score

    Positive health is assessed with the 17-item Positive Health measurement scale. scores range from 0-170 with higher scores indicating higher positive health.

    Measured: baseline, 3 months, 6 months, 12 months

  21. Self efficacy score

    Self-efficacy as assessed with the Dutch General Self-Efficacy scale (DGSES). The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

    Measured: baseline, 3 months, 6 months, 12 months

  22. Sleep quality score

    Sleep quality by means of Pittsburgh Sleep Quality Index (PSQI). A range of 0-21; higher scores indicate worse sleep quality.

    Measured: baseline, 3 months, 6 months, 12 months

  23. Medical consumption

    Medical consumption (incl. medication) by means of Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ)

    Measured: baseline, 3 months, 6 months, 12 months

  24. Productivity

    Productivity by means of Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)

    Measured: baseline, 3 months, 6 months, 12 months

  25. Cardiovascular condition

    Heart rate (bpm) 1 minute after 3-minute step test

    Measured: baseline, 6 months, 12 months

  26. Leg muscle strength

    Measured as time to perform the 5 times sit-to-stand test (sec)

    Measured: baseline, 6 months, 12 months

  27. Balance score

    Tandem Romberg test score, range 0-4 with higher scores indicating better balance

    Measured: baseline, 6 months, 12 months

  28. Flexibility

    Measured as distance between finger and toes when performing the chair sit-and-reach test (cm)

    Measured: baseline, 6 months, 12 months

  29. Hand grip strength

    Hand grip strength (kg) using a hand-held dynamometer

    Measured: baseline, 6 months, 12 months

  30. Skeletal muscle fat infiltration

    Echo intensity of the skeletal muscle rectus femoris (ultrasound)

    Measured: baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study start1 Nov 2022
  3. Primary completion31 Jul 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05666843
Sponsor's protocol ID
NL80697.091.22
Acronym
VJBD2
Status last verified
Dec 2024
First submitted
17 Nov 2022
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van Veldhuisen ER, van Damme I, Polhuis KCMM, Geleijnse JM, Winkels RM. The impact of a 6-month dietary counseling intervention on quality of life in individuals with type 2 diabetes: A secondary analysis of a randomized controlled trial. Clin Nutr ESPEN. 2026 Apr;72:102826. doi: 10.1016/j.clnesp.2025.11.146. Epub 2025 Nov 22.

    PubMed 41276175

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Dietary Advice in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Wageningen University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiometabolic risk profile (DIAL risk score) (time frame: Change from baseline at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05666843, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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