Cardiovascular Diseases, Diabetes Mellitus, Type 2
Conditions
Keywords
dietary guidelines, dietitian, dietary fiber, diabetes type 2, nutrition, randomized controlled trial (RCT), cardiovascular diseases
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.
Interventions
BEHAVIORALPersonalized 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.
Sponsors
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Hand grip strength | baseline, 6 months, 12 months | Hand grip strength (kg) using a hand-held dynamometer |
| 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. |
| Body weight (in kilograms) | baseline, 6 months, 12 months | As measured with a digital scale |
| Body mass index (kg/m^2) | baseline, 6 months, 12 months | Weight and height will be combined to report BMI in kg/m\^2. |
| Waist circumference | baseline, 6 months, 12 months | in centimeters |
| Blood lipids | baseline, 6 months, 12 months | Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides |
| 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. |
| 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 |
| Cardiovascular condition | baseline, 6 months, 12 months | Heart rate (bpm) 1 minute after 3-minute step test |
| C-peptide | baseline, 6 months, 12 month | As determined in blood samples |
| 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 |
| Liver function | baseline, 6 months, 12 months | Aspartate transaminase (AST) and Alanine transaminase (ALT) ratio as determined from blood sample |
| Inflammatory markers | baseline, 6 months, 12 months | hsCRP 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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) |
| Productivity | baseline, 3 months, 6 months, 12 months | Productivity by means of Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) |
| Skeletal muscle fat infiltration | baseline, 6 months, 12 months | Echo intensity of the skeletal muscle rectus femoris (ultrasound) |
| Fasting insulin | baseline, 6 months, 12 month | As determined in blood samples |
Countries
Netherlands
Outcome results
None listed