Effects of Peanut Intake on Cognitive Functions

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05532007
• Other study ID #: 5210436
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition
• Inflammation

Intervention

Dietary Supplement:
• Peanuts
2-3 ounces of peanuts to replace 20% of total daily energy intake

Other:
• Habitual Diet
continue with habitual diet and abstain from eating peanuts

Locations

Country	Name	City	State
United States	Loma Linda University School of Public Health	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	The Peanut Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	changes from baseline serum markers of inflammation	changes in serum inflammation markers which includes hs-CRP, IL-6, TNF-a, ICAM/VCAM, eSelectin, F2-isoprostanes, 8-hydroxy-deoxyguanosine (8-OH-dG) will all be assessed using ELISA	baseline to 12 weeks
Secondary	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	baseline to 12 weeks
Secondary	Change in serum brain-derived neurotrophic factor (pg/mL)	changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA	baseline to 12 weeks