CognitionNCT05532007
Effects of Peanut Intake on Cognitive Functions
A study testing Peanuts and Habitual Diet in people with Cognition and Inflammation, run by Loma Linda University at 1 site in United States.
Trial summary
The study will test the effects of Peanuts on task-related brain activation and cognitive functions in older adults with memory complaints. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Inflammation
- What is being tested?
- Peanuts and Habitual Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2022to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-demented elderly between 60-80 years of age
- Self-reported memory complaints
- Two cardiovascular risk factors
- Stable weight for at least 6 months prior to recruitment
Who cannot join
- Peanut allergy
- Smoker
- Endocrine, metabolic and neuropsychological disorders
- Ineligible to get an MRI
- Consuming more than 3 servings/week of nuts including peanuts
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University School of Public Health
Loma Linda, California, 92350
About this study
Official title: Effects of Peanut Intake on Task-related Brain Activation and Cognitive Functions in Older Adults With Memory Complaints: A Randomized Controlled Study
The study will test the effects of Peanuts on task-related brain activation and cognitive functions in older adults with memory complaints.
Read the detailed description
The purpose of the study is to determine the effects of peanuts on cognitive performance and task-related brain activation on functional magnetic resonance imaging (fMRI) in older adults. The specific aim of the study is to explore the neuroprotective effects of a peanut-enriched diet (2-3 oz of peanuts to replace 20% of the total energy of the habitual diet) for 12 weeks compared to a peanut-excluded habitual diet in elderly men and women with increased risk for CVD and self-reported memory complaints. The study population is older adults 60-80 years in age.
- Conditions
- Cognition, Inflammation
- Being tested
- Peanuts, Habitual Diet
- Keywords
- Peanuts, cognition, inflammation, oxidative stress
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeanutsDietary supplement
2-3 ounces of peanuts to replace 20% of total daily energy intake
Habitual DietOther
continue with habitual diet and abstain from eating peanuts
| Study group | Role | What they receive |
|---|---|---|
| Peanut Group | Active comparator | Peanuts: 2-3 ounces per day to replace 20% of daily energy intake Receives: Dietary Supplement: Peanuts |
| Control Group | Active comparator | Habitual diet abstain from eating peanuts Receives: Other: Habitual Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes from baseline in Brian activation
Changes will be assessed by Functional MRI (fMRI) on participants. there is no units of measure
Measured: baseline to 12 weeks
changes from baseline serum markers of inflammation
changes in serum inflammation markers which includes hs-CRP, IL-6, TNF-α, ICAM/VCAM, eSelectin, F2-isoprostanes, 8-hydroxy-deoxyguanosine (8-OH-dG) will all be assessed using ELISA
Measured: baseline to 12 weeks
Secondary outcomes (2)
changes from baseline in global cognitive composite score
The composite score will be calculated using the scores from the tests listed below. We will calculate the standardized scores of each test as the score of each participant minus the group mean and divide by its standard deviation. The composite score is the mean of the standardized scores. the 5 tests are: Rey Auditory Verbal Learning Test (RAVLT), Brief Visuospatial Memory Test, Digit Span, FAS Word Fluency, Symbol Digit Modalities Test
Measured: baseline to 12 weeks
Change in serum brain-derived neurotrophic factor (pg/mL)
changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start29 Mar 2022
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- This is a free living , randomized, controlled, parallel design study with 30 subjects, who will be randomized to either receive peanuts or abstain from them for 12 weeks.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- The Peanut Institute
- Responsible party
- Sponsor
- Investigators
- Sujatha Rajaram, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532007
- Sponsor's protocol ID
- 5210436
- Status last verified
- Apr 2025
- First submitted
- 31 Aug 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chiriac G, Barnes SR, Venezia JH, Lee GJ, Sabate J, Rajaram S. Effects of peanut consumption on task-related brain activation, cognition and neuroinflammation in older adults with memory complaints: a randomized controlled trial. Front Nutr. 2026 Aug 21;13:1817518. doi: 10.3389/fnut.2026.1817518. eCollection 2026.
PubMed 42698526
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peanut Intake on Task-related Brain Activation and Cognitive Functions in Older Adults With Memory Complaints: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05532007
- Acronym / sponsor ID
- 5210436
- Conditions
- Cognition, Inflammation
- Keywords
- Peanuts, cognition, inflammation, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- The Peanut Institute
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 8 Sep 2022 (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.
The study will test the effects of Peanuts on task-related brain activation and cognitive functions in older adults with memory complaints.
Detailed description
The purpose of the study is to determine the effects of peanuts on cognitive performance and task-related brain activation on functional magnetic resonance imaging (fMRI) in older adults. The specific aim of the study is to explore the neuroprotective effects of a peanut-enriched diet (2-3 oz of peanuts to replace 20% of the total energy of the habitual diet) for 12 weeks compared to a peanut-excluded habitual diet in elderly men and women with increased risk for CVD and self-reported memory complaints. The study population is older adults 60-80 years in age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a free living , randomized, controlled, parallel design study with 30 subjects, who will be randomized to either receive peanuts or abstain from them for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Peanut Group | Active comparator | Dietary Supplement: PeanutsPeanuts: 2-3 ounces per day to replace 20% of daily energy intake |
| Control Group | Active comparator | Other: Habitual DietHabitual diet abstain from eating peanuts |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-demented elderly between 60-80 years of age
- Self-reported memory complaints
- Two cardiovascular risk factors
- Stable weight for at least 6 months prior to recruitment
Key exclusion criteria (5 listed)
- Peanut allergy
- Smoker
- Endocrine, metabolic and neuropsychological disorders
- Ineligible to get an MRI
- Consuming more than 3 servings/week of nuts including peanuts
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 |
|---|---|---|
| Peanuts2-3 ounces of peanuts to replace 20% of total daily energy intake | Dietary supplement | Peanut Group |
| Habitual Dietcontinue with habitual diet and abstain from eating peanuts | Other | Control Group |
Primary outcome
changes from baseline in Brian activation
Time frame: baseline to 12 weeks
Changes will be assessed by Functional MRI (fMRI) on participants. there is no units of measure
changes from baseline serum markers of inflammation
Time frame: baseline to 12 weeks
changes in serum inflammation markers which includes hs-CRP, IL-6, TNF-α, ICAM/VCAM, eSelectin, F2-isoprostanes, 8-hydroxy-deoxyguanosine (8-OH-dG) will all be assessed using ELISA
2 secondary outcomes
changes from baseline in global cognitive composite score
Time frame: baseline to 12 weeks
Change in serum brain-derived neurotrophic factor (pg/mL)
Time frame: baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 42698526Chiriac G, Barnes SR, Venezia JH, Lee GJ, Sabate J, Rajaram S. Effects of peanut consumption on task-related brain activation, cognition and neuroinflammation in older adults with memory complaints: a randomized controlled trial. Front Nutr. 2026 Aug 21;13:1817518. doi: 10.3389/fnut.2026.1817518. eCollection 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. This study is not recruiting at the moment.
Sujatha Rajaram, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanuts and Habitual Diet in people with Cognition and Inflammation, run by Loma Linda University at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 6 Apr 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes from baseline in Brian activation (time frame: baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532007, which also lists 1 linked publication.
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 6 Apr 2025.