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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Usual care group | No Intervention | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline at 12 months |
| Body weight (in kilograms) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University and Research | Wageningen | Gelderland | 6708WE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41276175 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The nature of the intervention does not allow for blinding of the participants or researchers. After data collection, the database will be coded by an independent researcher to ensure that data analysis is conducted in a blinded way.
|
As measured with a digital scale |
| baseline, 6 months, 12 months |
| Body mass index (kg/m^2) | Weight and height will be combined to report BMI in kg/m^2. | baseline, 6 months, 12 months |
| Waist circumference | in centimeters | baseline, 6 months, 12 months |
| Blood lipids | Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides | baseline, 6 months, 12 months |
| 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. | baseline, 3 months, 6 months, 12 months |
| Micronutrient status | Micronutrient status as measured with biomarkers in blood and (24-hour) urine samples | baseline, 6 months, 12 months |
| 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. | baseline, 3 months, 6 months, 12 months |
| HbA1c | As determined in blood samples | baseline, 6 months, 12 month |
| Fasting glucose | As determined in blood samples | baseline, 6 months, 12 month |
| Fasting insulin | As determined in blood samples | baseline, 6 months, 12 month |
| C-peptide | As determined in blood samples | baseline, 6 months, 12 month |
| Blood pressure | Systolic and diastolic blood pressure (mmHg) as determined with a digital blood pressure monitor | baseline, 6 months, 12 months |
| Estimated Glomerular Filtration Rate (eGFR) | in ml/min/1,73 m2 as determined from blood sample | baseline, 6 months, 12 months |
| Urinary albumin levels | in grams per deciliter (g/dL) as determined from urine sample | baseline, 6 months, 12 months |
| Liver function | Aspartate transaminase (AST) and Alanine transaminase (ALT) ratio as determined from blood sample | baseline, 6 months, 12 months |
| Inflammatory markers | hsCRP in blood samples | baseline, 6 months, 12 months |
| 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. | baseline, 3 months, 6 months, 12 months |
| 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. | baseline, 3 months, 6 months, 12 months |
| 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. | baseline, 3 months, 6 months, 12 months |
| 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. | baseline, 3 months, 6 months, 12 months |
| Sleep quality score | Sleep quality by means of Pittsburgh Sleep Quality Index (PSQI). A range of 0-21; higher scores indicate worse sleep quality. | baseline, 3 months, 6 months, 12 months |
| Medical consumption | Medical consumption (incl. medication) by means of Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ) | baseline, 3 months, 6 months, 12 months |
| Productivity | Productivity by means of Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) | baseline, 3 months, 6 months, 12 months |
| Cardiovascular condition | Heart rate (bpm) 1 minute after 3-minute step test | baseline, 6 months, 12 months |
| Leg muscle strength | Measured as time to perform the 5 times sit-to-stand test (sec) | baseline, 6 months, 12 months |
| Balance score | Tandem Romberg test score, range 0-4 with higher scores indicating better balance | baseline, 6 months, 12 months |
| Flexibility | Measured as distance between finger and toes when performing the chair sit-and-reach test (cm) | baseline, 6 months, 12 months |
| Hand grip strength | Hand grip strength (kg) using a hand-held dynamometer | baseline, 6 months, 12 months |
| Skeletal muscle fat infiltration | Echo intensity of the skeletal muscle rectus femoris (ultrasound) | baseline, 6 months, 12 months |
| D004700 | Endocrine System Diseases |