Maastricht University Medical Center
Maastricht, Limburg, Netherlands
NCT Number: NCT05724654
Impaired brain vascular function precedes the development of reduced cognitive performance, while brain insulin-resistance is also associated with cognitive decline. Peanut consumption has already been shown to beneficially affect cognitive performance. However, underlying mechanisms have not yet been established, while well-controlled trials on longer-term effects of peanuts on cognitive performance are highly needed. The hypothesis is that longer-term peanut consumption has beneficial effects on (regional) cerebral blood flow responses (primary outcome), which may relate to an improved cognitive performance (secondary outcome) in older men and women. Important objectives are to investigate in older adults the effect of 16-week peanut consumption on (i) brain vascular function in cognitive-control brain areas, and (ii) brain insulin-sensitivity. We will also focus on changes in cognitive performance as assessed with a neuropsychological test battery (secondary objective). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin (brain insulin-sensitivity) will be quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).
Looking for future studies?
Notify Me60 year–75 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 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 skin roasted peanuts for 16 weeks.
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut 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 skin roasted peanut 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 skin roasted peanut intervention and 16-week control period.
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Transcranial Doppler (TCD) ultrasound will be used to assess the velocity of blood flow through the middle cerebral artery (MCA)
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Retinal images made by fundus camera
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Office blood pressure
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Office blood pressure
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Heart rate measured during office blood pressure measurement
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
High-Density Lipoprotein (HDL) cholesterol, Low-Density Lipoprotein (LDL) cholesterol, Total Cholesterol and Triglycerides will be assessed using clinical chemistry tests
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Glucose
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Insulin
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Markers for lysosomal damage (cathepsin-D and acid-phosphatase)
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Alanine Aminotransferase (ALT) level will be determined using clinical chemistry
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Aspartate Transaminase (AST) level will be determined using clinical chemistry
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Gamma-Glutamyl Transferase (GGT) level will be determined using clinical chemistry
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Bilirubin level will be determined using clinical chemistry
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Cytokeratin-18 (CK-18) level will be determined using clinical chemistry
Time frame: Change in outcomes at baseline before a 16-week skin roasted peanut intervention and 16-week control period.
DNA from leucocytes will be analyzed for the presence of known SNPs in genes encoding proteins known to play a role in cholesterol metabolism.
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
High-resolution anatomical MPRAGE scan
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Magnetic Resonance Imaging measurements will be included to quantify abdominal fat compartments (i.e. subcutaneous and visceral fat)
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Magnetic Resonance Imaging measurements will be included to quantify liver fat content
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut 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 skin roasted peanut 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 skin roasted peanut 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 skin roasted peanut intervention and 16-week control period.
Stress will be assessed using the Perceived Stress Scale (PSS)
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Timed up-and-go test (TUGT)
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut 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 skin roasted peanut intervention and 16-week control period.
Handgrip test
Time frame: Change in outcomes will be compared at baseline, at 8-weeks and at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Weight in kilograms
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Waist circumference in centimeters
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Hip circumference in centimeters
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Measured by skinfold measurements
Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Food intake will be assessed using the Food Frequency Questionnaire
Maastricht University Medical Center
Other
Longer-term Effects of Peanut Consumption on Brain Function in Older Men and Women
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