About this trial
Healthy foods, including peanuts, may improve brain function, which is essential for cognitive and metabolic health, and may contribute to improved food intake regulation. It is therefore important to investigate the specific effects of peanut butter on cerebral blood flow responses, as well as the potential associated functional benefits. The researchers hypothesize that long-term peanut butter consumption improves vascular function in the brain, thereby enhancing cognitive performance and appetite control in middle aged and older adults. Objective: The primary objectives are to investigate in middle aged and older men and women the effect of 16-week peanut butter consumption on brain vascular function, while we will also assess changes in cognitive performance and appetite-related brain reward activity (secondary objectives). Cerebral blood flow responses (brain vascular function) will be non-invasively quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).Study design: This intervention study will have a randomized, controlled, cross-over design. The total study duration will be 40 weeks, including two 16-week interventions, separated by a washout period of at least 8 weeks. Study population: Forty-five middle-aged and older men and women (aged 45-75 years) without a history of cardiovascular diseases or complaints will participate. This population is expected to have a decreased cerebral blood flow at baseline and are also at increased risk of cognitive impairment, allowing for improvement by the intervention. Intervention: Study participants will receive, in random order, 45 g of peanut butter daily (peanut intervention) or no peanut butter (control) for a total of 16 weeks, separated by a wash-out period of at least 8 weeks. Main study parameters/endpoints: At baseline, first anthropometric measurements will be performed and blood pressure will be determined. In addition, a fasting blood sample will be drawn. Another fasting blood sample will be drawn at eight weeks, while participants have to attend the research facilities to perform follow-up measurements after sixteen weeks. The primary endpoint is the difference at follow-up in the cerebral blood flow response between peanut butter intervention and control periods. Cognitive performance will be assessed, while the researchers will also focus on appetite-related brain reward activity (secondary outcomes).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men and women, aged between 45-75 years
Women postmenopausal: two or more years after last menstruation
Fasting plasma glucose < 7.0 mmol/L
Fasting serum total cholesterol < 8.0 mmol/L
Disqualifiers
Allergy or intolerance to peanuts
Left-handedness (effects on brain health differ between left- and right-handed adults)
Current smoker, or smoking cessation < 12 months
Diabetic patients
Trial design
Crossover
Treatments tested in this trial
Peanut butter
Other interventionStudy participants will receive daily 45 g of peanut butter for 16 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Cerebral blood flow by pseudo-continuous arterial spin labeling magnetic resonance imaging
Cerebral blood flow (CBF) will be non-invasively measured using the gold-standard methodology pseudo-continuous arterial spin labeling magnetic resonance imaging (pCASL MRI).
Secondary outcomes
Cognitive function by the Cambridge Neuropsychological Test Automated Battery
Cognitive performance measurement of the following cognitive domains: memory, executive function and psychomotor speed. All of the domains will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Daily cognitive function by the ecological momentary assessment instruments
The daily assessment includes three validated ultra-brief 'games' that aims to assess spatial working memory, associative working memory, and attention and executive function through the ecological momentary assessment notified modules.
Blood oxygen level-dependent functional magnetic resonance imaging activity
To measure appetite-related brain reward activity, blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) activity will be measured before and while participants watch food pictures.
Other outcomes
Perceived hunger and satiety by visual analogue scales
Satiety will be assessed during an ad libitum test meal with visual analogue scales (VAS).
Concentration of postprandial glucagon-like peptide 1 level in plasma
Mood score by Profile of Mood States (POMS)
Mood will be tested using the widely applied Profile of Mood States (POMS), which is a standard validated psychological test for the assessment of an individual's mood.
Stress score by the Perceived Stress Scale (PSS)
Sponsors and contacts
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