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Effects of Peanut Intake on Cognitive Functions

Primary Purpose

Cognition, Inflammation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peanuts
Habitual Diet
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognition focused on measuring Peanuts, cognition, inflammation, oxidative stress

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loma Linda University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Peanut Group

Control Group

Arm Description

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

Habitual diet abstain from eating peanuts

Outcomes

Primary Outcome Measures

changes from baseline in Brian activation
Changes will be assessed by Functional MRI (fMRI) on participants. there is no units of measure
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

Secondary Outcome Measures

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
Change in serum brain-derived neurotrophic factor (pg/mL)
changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA

Full Information

First Posted
August 31, 2022
Last Updated
November 29, 2022
Sponsor
Loma Linda University
Collaborators
The Peanut Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05532007
Brief Title
Effects of Peanut Intake on Cognitive Functions
Official Title
Effects of Peanut Intake on Task-related Brain Activation and Cognitive Functions in Older Adults With Memory Complaints: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
Collaborators
The Peanut Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition, Inflammation
Keywords
Peanuts, cognition, inflammation, oxidative stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peanut Group
Arm Type
Active Comparator
Arm Description
Peanuts: 2-3 ounces per day to replace 20% of daily energy intake
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Habitual diet abstain from eating peanuts
Intervention Type
Dietary Supplement
Intervention Name(s)
Peanuts
Intervention Description
2-3 ounces of peanuts to replace 20% of total daily energy intake
Intervention Type
Other
Intervention Name(s)
Habitual Diet
Intervention Description
continue with habitual diet and abstain from eating peanuts
Primary Outcome Measure Information:
Title
changes from baseline in Brian activation
Description
Changes will be assessed by Functional MRI (fMRI) on participants. there is no units of measure
Time Frame
baseline to 12 weeks
Title
changes from baseline serum markers of inflammation
Description
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
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
changes from baseline in global cognitive composite score
Description
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
Time Frame
baseline to 12 weeks
Title
Change in serum brain-derived neurotrophic factor (pg/mL)
Description
changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA
Time Frame
baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujatha Rajaram, PhD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University School of Public Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

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Effects of Peanut Intake on Cognitive Functions

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