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Completed

NCT Number: NCT05532007

Effects of Peanut Intake on Cognitive Functions

The study will test the effects of Peanuts on task-related brain activation and cognitive functions in older adults with memory complaints.

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Key information

Conditions

Cognition Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peanuts

Dietary Supplement

2-3 ounces of peanuts to replace 20% of total daily energy intake

habitual diet

Other

continue with habitual diet and abstain from eating peanuts

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • The Peanut Institute

Registry information

Official study title

Effects of Peanut Intake on Task-related Brain Activation and Cognitive Functions in Older Adults With Memory Complaints: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 8, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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