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…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in change in cardiometabolic risk
profile (HbA1c, LDL-cholesterol, blood pressure and body weight) from baseline
until six months between the intervention and the control group.
Secondary outcome
Secondary parameters include a diet quality score for the level of adherence to
the Dutch dietary guidelines, blood lipid profile, markers of glucose
metabolism, kidney, and liver function, muscle quality and physical
performance, patient-oriented outcomes such as medical consumption,
productivity, sleep quality, food literacy, quality of life and self-efficacy.
These parameters are assessed in blood and 24-hour urine, and by means of
measuring body weight, blood pressure, making ultrasound of the leg, fitness
tests, a dietary recall, and self-administered questionnaires. To assess
whether effects remain after the active intervention period has ended,
differences in change between intervention and control group will also be
investigated six months after the intervention, i.e. 12 months after the start
of the study.
Background summary
Type 2 diabetes has a major impact on an individual*s life and can lead to
physical and psychological distress. There is need for interventions that not
only improve glucose levels, but also address other health indicators such as
comorbidities and mental aspects of the disease. A healthy diet is of key
importance in the management of type 2 diabetes, with dietary fibres as a
critical component. However, the broad health effects of an increased intake of
fibre-rich foods, as recommended in the Dutch dietary guidelines, remain
unclear for individuals with type 2 diabetes. Intake levels in the Dutch
population are below the recommendation, and interventions using high
fibre-diets are mostly conducted with dietary fibre supplements. Previous
interventions with fibre supplements show promising results among individuals
with type 2 diabetes, but whether these effects are similar when adhering to
the dietary guidelines without the use of fibre supplements, remains unclear.
Study objective
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. Secondary
objectives are to investigate the effects on the level of adherence to the
Dutch dietary guidelines, diabetes related health outcomes, including markers
of glucose metabolism, lipid profile, kidney function, liver function and
inflammatory markers, patient-oriented outcomes, including quality of life,
self-efficacy, medical consumption, productivity and sleep quality, and muscle
quality and physical performance.
Study design
The study will be a parallel randomized, controlled trial over a period of
twelve months, including an intervention period of six months and a follow up
period of six months in which no active intervention takes place.
Intervention
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 adherence to dietary guidelines, current dietary intake,
gender and personal goals and preferences.
Study burden and risks
Participants in the intervention group will meet with a dietician, by which
they will be guided to adjust their dietary intake. Over a period of twelve
months, all participants will be asked to complete questionnaires and dietary
recalls at four different time points. At three time points, body weight, blood
pressure, blood samples, and 24hr urine samples are obtained. An ultrasound of
the leg and a fitness test are performed at these three time points as well.
Benefits for participants include probable improvements of cardiometabolic risk
factors which favourably impacts their cardiometabolic health and quality of
life. The study can be beneficial for individuals with type 2 diabetes, as the
results could lead to improved dietary guidelines for this group.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80697.091.22 |
| Other | Registratie volgt na besluit |