Effects of Peanut Intake on Cognitive Functions

NCT ID: NCT05532007

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2022-10-26

Brief Summary

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

Detailed Description

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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

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Cognition Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
The participants will be aware if they received the intervention or not, however, the cognitive testers and FMRI techs would not be aware of the participant randomization group and neither will the data analyst.

Study Groups

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Peanut Group

Peanuts: 2-3 ounces per day to replace 20% of daily energy intake

Group Type ACTIVE_COMPARATOR

Peanuts

Intervention Type DIETARY_SUPPLEMENT

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

Control Group

Habitual diet abstain from eating peanuts

Group Type ACTIVE_COMPARATOR

Habitual Diet

Intervention Type OTHER

continue with habitual diet and abstain from eating peanuts

Interventions

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Peanuts

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

Intervention Type DIETARY_SUPPLEMENT

Habitual Diet

continue with habitual diet and abstain from eating peanuts

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Peanut Institute

OTHER

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sujatha Rajaram, PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

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Loma Linda University School of Public Health

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5210436

Identifier Type: -

Identifier Source: org_study_id

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