Peanut Butter and Brain Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorPenn State University

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Peanut butter

    Other intervention

    Study participants will receive daily 45 g of peanut butter for 16 weeks.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Peanut butterExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
At the end of both the 16-week peanut butter intervention and the 16-week control periods.

Secondary outcomes

1

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).

Time frame
At the beginning and end of both the 16-week peanut butter intervention and the 16-week control periods.
2

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.

Time frame
A 7-day period prior to the beginning and at the end of the 16-week peanut butter intervention and the 16-week control periods.
3

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.

Time frame
At the end of both the 16-week peanut butter intervention and the 16-week control periods.

Other outcomes

1

Perceived hunger and satiety by visual analogue scales

Satiety will be assessed during an ad libitum test meal with visual analogue scales (VAS).

Time frame
At the end of both the 16-week peanut butter intervention and the 16-week control periods
2

Concentration of postprandial glucagon-like peptide 1 level in plasma

Time frame
At the end of both the 16-week peanut butter intervention and the 16-week control periods
3

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.

Time frame
At the beginning and end of both the 16-week peanut butter intervention and the 16-week control periods.
4

Stress score by the Perceived Stress Scale (PSS)

Time frame
At the beginning and end of both the 16-week peanut butter intervention and the 16-week control periods.

Sponsors and contacts

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