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

Wageningen University

Status: Completed

Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Behavioral: Personalized Dietary Advice

Study type: Interventional

Funder types: Other

Identifiers

NCT05666843

NL80697.091.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Personalized Dietary Advice

Usual care group

No Intervention group

Description:

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.