Voed je beter met diabetes type 2: The effects of personalized dietary guidance to increase the intake of fibre-rich foods on cardiometabolic risk profile in individuals with type 2 diabetes

Recruiting

Conditions: non-insulin-dependent diabetes
10018424
type 2 diabetes

Registration Number: NL-OMON51759

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 168

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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in change in cardiometabolic risk<br /><br>profile (HbA1c, LDL-cholesterol, blood pressure and body weight) from baseline<br /><br>until six months between the intervention and the control group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters include a diet quality score for the level of adherence to<br />the Dutch dietary guidelines, blood lipid profile, markers of glucose<br />metabolism, kidney, and liver function, muscle quality and physical<br />performance, patient-oriented outcomes such as medical consumption,<br />productivity, sleep quality, food literacy, quality of life and self-efficacy.<br />These parameters are assessed in blood and 24-hour urine, and by means of<br />measuring body weight, blood pressure, making ultrasound of the leg, fitness<br />tests, a dietary recall, and self-administered questionnaires. To assess<br />whether effects remain after the active intervention period has ended,<br />differences in change between intervention and control group will also be<br />investigated six months after the intervention, i.e. 12 months after the start<br />of the study.</p>