Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals with Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2Cardiovascular Diseases
- Interventions
- Behavioral: Personalized Dietary Advice
- Registration Number
- NCT05666843
- Lead Sponsor
- Wageningen University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Personalized Dietary Advice 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 Outcome Measures
Name Time Method Cardiometabolic risk profile (DIAL risk score) 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 Outcome Measures
Name Time Method Cardiometabolic risk profile (DIAL risk score) 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.
Liver function baseline, 6 months, 12 months Aspartate transaminase (AST) and Alanine transaminase (ALT) ratio as determined from blood sample
Health index score 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.
Hand grip strength baseline, 6 months, 12 months Hand grip strength (kg) using a hand-held dynamometer
Skeletal muscle fat infiltration baseline, 6 months, 12 months Echo intensity of the skeletal muscle rectus femoris (ultrasound)
Dietary intake 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.
Productivity baseline, 3 months, 6 months, 12 months Productivity by means of Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)
Leg muscle strength baseline, 6 months, 12 months Measured as time to perform the 5 times sit-to-stand test (sec)
Balance score baseline, 6 months, 12 months Tandem Romberg test score, range 0-4 with higher scores indicating better balance
Flexibility baseline, 6 months, 12 months Measured as distance between finger and toes when performing the chair sit-and-reach test (cm)
Body weight (in kilograms) baseline, 6 months, 12 months As measured with a digital scale
Blood pressure baseline, 6 months, 12 months Systolic and diastolic blood pressure (mmHg) as determined with a digital blood pressure monitor
Estimated Glomerular Filtration Rate (eGFR) baseline, 6 months, 12 months in ml/min/1,73 m2 as determined from blood sample
Urinary albumin levels baseline, 6 months, 12 months in grams per deciliter (g/dL) as determined from urine sample
Inflammatory markers baseline, 6 months, 12 months hsCRP in blood samples
Self efficacy score 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.
Body mass index (kg/m^2) baseline, 6 months, 12 months Weight and height will be combined to report BMI in kg/m\^2.
Blood lipids baseline, 6 months, 12 months Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides
Micronutrient status baseline, 6 months, 12 months Micronutrient status as measured with biomarkers in blood and (24-hour) urine samples
Food literacy 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.
HbA1c baseline, 6 months, 12 month As determined in blood samples
Fasting glucose baseline, 6 months, 12 month As determined in blood samples
Fasting insulin baseline, 6 months, 12 month As determined in blood samples
Sleep quality score 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.
Cardiovascular condition baseline, 6 months, 12 months Heart rate (bpm) 1 minute after 3-minute step test
Waist circumference baseline, 6 months, 12 months in centimeters
C-peptide baseline, 6 months, 12 month As determined in blood samples
Quality of life score 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.
Positive health score 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.
Medical consumption baseline, 3 months, 6 months, 12 months Medical consumption (incl. medication) by means of Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ)
Trial Locations
- Locations (1)
Wageningen University and Research
🇳🇱Wageningen, Gelderland, Netherlands