Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals with Type 2 Diabetes (VJBD2)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Personalized Dietary Advice

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708WE
      • Wageningen University and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Behavioral: 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.
No Intervention: Usual care group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Wageningen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: December 18, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: nutrition; cardiovascular diseases; dietary fiber; dietitian; randomized controlled trial (RCT); diabetes type 2; dietary guidelines
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Diabetes Mellitus
• Other Study ID Numbers: NL80697.091.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No