Clinical trial NCT05666843: Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes
Official title: The Effects of Personalized Dietary Guidance to Increase the Intake of Fibre-rich Foods on Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes. (in Dutch: Voed je Beter Met Diabetes Type 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Cardiovascular Diseases
Keywords: dietary guidelines
dietitian
dietary fiber
diabetes type 2
nutrition
randomized controlled trial (RCT)
cardiovascular diseases
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiometabolic risk profile (DIAL risk score)
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: Cardiometabolic risk profile (DIAL risk score)
timeFrame: Change from baseline at 12 months
measure: Body weight (in kilograms)
timeFrame: baseline, 6 months, 12 months
measure: Body mass index (kg/m^2)
timeFrame: baseline, 6 months, 12 months
measure: Waist circumference
timeFrame: baseline, 6 months, 12 months
measure: Blood lipids
timeFrame: baseline, 6 months, 12 months
measure: Dietary intake
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Micronutrient status
timeFrame: baseline, 6 months, 12 months
measure: Food literacy
timeFrame: baseline, 3 months, 6 months, 12 months
measure: HbA1c
timeFrame: baseline, 6 months, 12 month
measure: Fasting glucose
timeFrame: baseline, 6 months, 12 month
measure: Fasting insulin
timeFrame: baseline, 6 months, 12 month
measure: C-peptide
timeFrame: baseline, 6 months, 12 month
measure: Blood pressure
timeFrame: baseline, 6 months, 12 months
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: baseline, 6 months, 12 months
measure: Urinary albumin levels
timeFrame: baseline, 6 months, 12 months
measure: Liver function
timeFrame: baseline, 6 months, 12 months
measure: Inflammatory markers
timeFrame: baseline, 6 months, 12 months
measure: Quality of life score
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Health index score
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Positive health score
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Self efficacy score
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Sleep quality score
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Medical consumption
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Productivity
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Cardiovascular condition
timeFrame: baseline, 6 months, 12 months
measure: Leg muscle strength
timeFrame: baseline, 6 months, 12 months
measure: Balance score
timeFrame: baseline, 6 months, 12 months
measure: Flexibility
timeFrame: baseline, 6 months, 12 months
measure: Hand grip strength
timeFrame: baseline, 6 months, 12 months
measure: Skeletal muscle fat infiltration
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University and Research
state: Gelderland
Study officials:
References: