- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05532007
Effects of Peanut Intake on Cognitive Functions
April 4, 2025 updated by: Loma Linda University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Loma Linda University School of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Peanut allergy
- Smoker
- Endocrine, metabolic and neuropsychological disorders
- Ineligible to get an MRI
- Consuming more than 3 servings/week of nuts including peanuts
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Peanut Group
Peanuts: 2-3 ounces per day to replace 20% of daily energy intake
|
2-3 ounces of peanuts to replace 20% of total daily energy intake
|
|
Active Comparator: Control Group
Habitual diet abstain from eating peanuts
|
continue with habitual diet and abstain from eating peanuts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline to 12 weeks
|
|
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
|
baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes from baseline in global cognitive composite score
Time Frame: baseline to 12 weeks
|
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
|
baseline to 12 weeks
|
|
Change in serum brain-derived neurotrophic factor (pg/mL)
Time Frame: baseline to 12 weeks
|
changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA
|
baseline to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sujatha Rajaram, PhD, Loma Linda University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2022
Primary Completion (Actual)
October 26, 2022
Study Completion (Actual)
October 26, 2022
Study Registration Dates
First Submitted
August 31, 2022
First Submitted That Met QC Criteria
September 6, 2022
First Posted (Actual)
September 8, 2022
Study Record Updates
Last Update Posted (Actual)
April 6, 2025
Last Update Submitted That Met QC Criteria
April 4, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5210436
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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