Effects of Peanut Intake on Cognitive Functions

NCT05532007 | Completed

• 1 other identifier: 5210436
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognition; Inflammation

Keywords

Peanuts; cognition; inflammation; oxidative stress

Outcome Measures

Primary Outcomes (2)

• changes from baseline in Brian activation

  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

  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 Outcomes (2)

• changes from baseline in global cognitive composite score

  baseline to 12 weeks

• Change in serum brain-derived neurotrophic factor (pg/mL)

  baseline to 12 weeks

Study Arms (2)

Peanut Group

ACTIVE COMPARATOR

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

Dietary Supplement: Peanuts

Control Group

ACTIVE COMPARATOR

Habitual diet abstain from eating peanuts

Other: Habitual Diet

Interventions

Peanuts DIETARY_SUPPLEMENT

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

Peanut Group

Habitual Diet OTHER

continue with habitual diet and abstain from eating peanuts

Control Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Peanut allergy
• Smoker
• Endocrine, metabolic and neuropsychological disorders
• Ineligible to get an MRI
• Consuming more than 3 servings/week of nuts including peanuts

Sponsors & Collaborators

• Loma Linda University: lead
• The Peanut Institute: collaborator

Study Sites (1)

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sujatha Rajaram, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 8, 2022
• Study Start: March 29, 2022
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (1)