Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes
NCT ID: NCT05666843
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2022-11-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Wageningen University
OTHER
Responsible Party
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Marianne Geleijnse
prof.dr. JM (Marianne) Geleijnse
Locations
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Wageningen University and Research
Wageningen, Gelderland, Netherlands
Countries
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Other Identifiers
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NL80697.091.22
Identifier Type: -
Identifier Source: org_study_id
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