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Completed

NCT Number: NCT05666843

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University and Research

Wageningen, Gelderland, 6708WE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Personalized dietary advice

Behavioral

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.

Primary outcomes

  1. Cardiometabolic risk profile (DIAL risk score)

    Time frame: Change from baseline at 6 months

    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.

Secondary outcomes

  1. Cardiometabolic risk profile (DIAL risk score)

    Time frame: Change from baseline at 12 months

    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.

  2. Body weight (in kilograms)

    Time frame: baseline, 6 months, 12 months

    As measured with a digital scale

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

    Time frame: baseline, 6 months, 12 months

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

  4. Waist circumference

    Time frame: baseline, 6 months, 12 months

    in centimeters

  5. Blood lipids

    Time frame: baseline, 6 months, 12 months

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

  6. Dietary intake

    Time frame: baseline, 3 months, 6 months, 12 months

    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.

  7. Micronutrient status

    Time frame: baseline, 6 months, 12 months

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

  8. Food literacy

    Time frame: baseline, 3 months, 6 months, 12 months

    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.

  9. HbA1c

    Time frame: baseline, 6 months, 12 month

    As determined in blood samples

  10. Fasting glucose

    Time frame: baseline, 6 months, 12 month

    As determined in blood samples

  11. Fasting insulin

    Time frame: baseline, 6 months, 12 month

    As determined in blood samples

  12. C-peptide

    Time frame: baseline, 6 months, 12 month

    As determined in blood samples

  13. Blood pressure

    Time frame: baseline, 6 months, 12 months

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

  14. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: baseline, 6 months, 12 months

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

  15. Urinary albumin levels

    Time frame: baseline, 6 months, 12 months

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

  16. Liver function

    Time frame: baseline, 6 months, 12 months

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

  17. Inflammatory markers

    Time frame: baseline, 6 months, 12 months

    hsCRP in blood samples

  18. Quality of life score

    Time frame: baseline, 3 months, 6 months, 12 months

    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.

  19. Health index score

    Time frame: baseline, 3 months, 6 months, 12 months

    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.

  20. Positive health score

    Time frame: baseline, 3 months, 6 months, 12 months

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

  21. Self efficacy score

    Time frame: baseline, 3 months, 6 months, 12 months

    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.

  22. Sleep quality score

    Time frame: baseline, 3 months, 6 months, 12 months

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

  23. Medical consumption

    Time frame: baseline, 3 months, 6 months, 12 months

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

  24. Productivity

    Time frame: baseline, 3 months, 6 months, 12 months

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

  25. Cardiovascular condition

    Time frame: baseline, 6 months, 12 months

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

  26. Leg muscle strength

    Time frame: baseline, 6 months, 12 months

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

  27. Balance score

    Time frame: baseline, 6 months, 12 months

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

  28. Flexibility

    Time frame: baseline, 6 months, 12 months

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

  29. Hand grip strength

    Time frame: baseline, 6 months, 12 months

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

  30. Skeletal muscle fat infiltration

    Time frame: baseline, 6 months, 12 months

    Echo intensity of the skeletal muscle rectus femoris (ultrasound)

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study 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)

Acronym: VJBD2

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 28, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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