Healthy AgingNCT07774546
Peanut Butter and Brain Health
A study testing Peanut butter in people with Healthy Aging and Middle-aged and Older Adults, run by Penn State University at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Middle-aged and Older Adults
- What is being tested?
- Peanut butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Fasting serum triacylglycerol < 4.5 mmol/L
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
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- Stable body weight (weight gain or loss < 3 kg in the past three months)
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks
- after completion of the study
- No difficult venipuncture as evidenced during the screening visit
Who cannot join
- 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
- Familial hypercholesterolemia
- Abuse of drugs
Show all 13Show fewer
- More than 3 alcoholic consumptions per day
- Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
- Use of medication to treat blood pressure, lipid, or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases, and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Maastricht University Medical Center
Maastricht
Peter J Joris, +31883887250, p.joris@maastrichtuniversity.nl
About this study
Official title: Long-term Peanut Butter Consumption and Brain Health in Humans
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).
- Conditions
- Healthy Aging, Middle-aged and Older Adults
- Being tested
- Peanut butter
- Keywords
- Peanuts, Peanut butter, Brain, Cognitive health, Metabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut butterOther
Study participants will receive daily 45 g of peanut butter for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Peanut butter | Experimental | Study participants will receive daily 45 g of peanut butter during the 16-week intervention period. Receives: Other: Peanut butter |
| Control | No intervention | Study participants will not consume the study peanut butter during the 16-week control period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the end of both the 16-week peanut butter intervention and the 16-week control periods.
Secondary outcomes (3)
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).
Measured: At the beginning and end of both the 16-week peanut butter intervention and the 16-week control periods.
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.
Measured: 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.
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.
Measured: At the end of both the 16-week peanut butter intervention and the 16-week control periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This intervention study will have a randomized, controlled, cross-over design. 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muzi Na, Penn State University
- Investigators
- Peter J Joris, Principal investigator, Maastricht University Medical CenterMuzi Na, Principal investigator, Penn State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774546
- Sponsor's protocol ID
- STUDY00028064
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Peanut Butter Consumption and Brain Health in Humans
- ClinicalTrials.gov ID
- NCT07774546
- Acronym / sponsor ID
- STUDY00028064
- Conditions
- Healthy Aging, Middle-aged and Older Adults
- Keywords
- Peanuts, Peanut butter, Brain, Cognitive health, Metabolic health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This intervention study will have a randomized, controlled, cross-over design. 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.
| Arm | Type | Receives |
|---|---|---|
| Peanut butter | Experimental | Other: Peanut butterStudy participants will receive daily 45 g of peanut butter during the 16-week intervention period. |
| Control | No intervention | –Study participants will not consume the study peanut butter during the 16-week control period. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Fasting serum triacylglycerol < 4.5 mmol/L
Key exclusion criteria (13 listed)
- 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
- Familial hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut butterStudy participants will receive daily 45 g of peanut butter for 16 weeks. | Other | Peanut butter |
Primary outcome
Cerebral blood flow by pseudo-continuous arterial spin labeling magnetic resonance imaging
Time frame: At the end of both the 16-week peanut butter intervention and the 16-week control periods.
Cerebral blood flow (CBF) will be non-invasively measured using the gold-standard methodology pseudo-continuous arterial spin labeling magnetic resonance imaging (pCASL MRI).
3 secondary outcomes
Cognitive function by the Cambridge Neuropsychological Test Automated Battery
Time frame: At the beginning and end of both the 16-week peanut butter intervention and the 16-week control periods.
Daily cognitive function by the ecological momentary assessment instruments
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.
Blood oxygen level-dependent functional magnetic resonance imaging activity
Time frame: At the end of both the 16-week peanut butter intervention and the 16-week control periods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter J Joris principal investigator
Maastricht University Medical Center
Muzi Na principal investigator
Penn State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut butter in people with Healthy Aging and Middle-aged and Older Adults, run by Penn State University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter J Joris, PhD (+31883887250, p.joris@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow by pseudo-continuous arterial spin labeling magnetic resonance imaging (time frame: At the end of both the 16-week peanut butter intervention and the 16-week control periods.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.