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

NCT05666843 | Completed

• 1 other identifier: NL80697.091.22
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

dietary guidelines; dietitian; dietary fiber; diabetes type 2; nutrition; randomized controlled trial (RCT); cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (30)

• Cardiometabolic risk profile (DIAL risk score)

  Change from baseline at 12 months

• Body weight (in kilograms)

  baseline, 6 months, 12 months

• Body mass index (kg/m^2)

  baseline, 6 months, 12 months

• Waist circumference

  baseline, 6 months, 12 months

• Blood lipids

  baseline, 6 months, 12 months

Study Arms (2)

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.

Behavioral: Personalized Dietary Advice

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University and Research

Wageningen, Gelderland, 6708WE, Netherlands

Location

Related Publications (1)

• 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. 2025 Nov 22:102826. doi: 10.1016/j.clnesp.2025.11.146. Online ahead of print.

  PMID: 41276175 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr. JM (Marianne) Geleijnse

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 28, 2022
• Study Start: November 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2025

Record last verified: 2024-12

Locations

NL (1)