Maastricht University Medical Center
Maastricht, Limburg, 6229 ER, Netherlands
NCT Number: NCT04210869
Impaired brain vascular function precedes the development of reduced cognitive performance, while brain insulin-resistance is also associated with cognitive decline. The Mediterranean diet, which is rich in nuts, may protect against the development of impaired cognitive performance. The hypothesis is that long-term mixed nut consumption increases brain insulin-sensitivity thereby improving brain vascular function and cognitive performance. The primary objective is to evaluate in elderly men and women the effect of 16-week mixed nut consumption on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to investigate effects on the cerebral blood flow response to intranasal insulin delivery - a marker of insulin-sensitivity in the human brain - as quantified by ASL, and cognitive functioning as assessed with a neuropsychological test battery.
Looking for future studies?
Notify Me60 year–70 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 6229 ER, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study volunteers will receive daily 60 g of mixed nuts (15 g walnut, 15 g cashew, 15 g hazelnut, 15 g pistachio) for 16 weeks.
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Change in cerebral blood flow, as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL), before and after application of intranasal insulin (160 IU)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Oral Glucose Tolerance Test (OGTT)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Flow-mediated vasodilation (FMD)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Carotid artery reactivity (CAR)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Pulse wave analysis (PWA)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Pulse wave velocity (PWV)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Retinal microvascular calibers
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Office and 24-hour ambulatory blood pressure
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Serum protein-bound advanced glycation endproducts (AGEs)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Lipids and Lipoproteins
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Glucose
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Insulin
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Markers for low-grade systemic inflammation (IL-6, TNF-alpha)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Markers for microvascular function (sCAM-1, vWf, cGMP)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Brain-derived neurotrophic factor
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Alpha-linoleic acid levels (blood)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
MRI Structural MPRAGE scan
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Resting and task-induced blood-oxygen-level-dependent (BOLD) response, as quantified by functional MRI T2*-weighted imaging.
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Magnetic Resonance Imaging measurements will be included to quantify abdominal fat compartments (i.e.
subcutaneous and visceral fat) and fat content of abdominal organs (i.e. liver and pancreas).
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Fecal samples will be collected to be used for analysing different species of microbiota.
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
The Quality of life will be assessed using a 32-item questionnaire
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Mood will be tested using the Affect Grid
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Timed up-and-go test (TUGT)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
The 6-minute walk test (6 MWT)
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Handgrip test
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Muscle strength test, as measured using the Biodex system
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Weight in kilograms
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Length in meters
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Waist circumference in centimeters
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Hip circumference in centimeters
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Measured by skinfold measurements
Time frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Food intake will be assessed using the Food Frequency Questionnaire
Maastricht University Medical Center
Other
The Long-Term Effects of Mixed Nuts Consumption on Brain Vascular Function in Elderly Men and Women
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