Effects of Peanut Consumption on Brain Function

July 25, 2024 updated by: Maastricht University Medical Center

Longer-term Effects of Peanut Consumption on Brain Function in Older Men and Women

Impaired brain vascular function precedes the development of reduced cognitive performance, while brain insulin-resistance is also associated with cognitive decline. Peanut consumption has already been shown to beneficially affect cognitive performance. However, underlying mechanisms have not yet been established, while well-controlled trials on longer-term effects of peanuts on cognitive performance are highly needed. The hypothesis is that longer-term peanut consumption has beneficial effects on (regional) cerebral blood flow responses (primary outcome), which may relate to an improved cognitive performance (secondary outcome) in older men and women. Important objectives are to investigate in older adults the effect of 16-week peanut consumption on (i) brain vascular function in cognitive-control brain areas, and (ii) brain insulin-sensitivity. We will also focus on changes in cognitive performance as assessed with a neuropsychological test battery (secondary objective). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin (brain insulin-sensitivity) will be quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men and women, aged between 60-75 years
  • BMI between 20-35 kg/m2
  • Fasting plasma glucose < 7.0 mmol/L
  • Fasting serum total cholesterol < 8.0 mmol/L
  • Fasting serum triacylglycerol < 4.5 mmol/L
  • Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
  • Stable body weight (weight gain or loss < 3 kg in the past three months)
  • Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
  • No difficult venipuncture as evidenced during the screening visit

Exclusion Criteria:

  • Allergy or intolerance to peanuts
  • Left-handedness
  • Current smoker, or smoking cessation < 12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
  • More than 3 alcoholic consumptions per day
  • Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
  • Use medication to treat blood pressure, lipid, or glucose metabolism
  • Use of an investigational product within another biomedical intervention trial within the previous 1-month
  • Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases, and rheumatoid arthritis
  • Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
  • Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Skin roasted peanuts
Dietary supplement: Skin roasted peanuts
Study volunteers will receive daily 60 g of skin roasted peanuts for 16 weeks.
No Intervention: Control
No skin roasted peanuts

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brain Vascular Function
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Brain Insulin Sensitivity
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Change in cerebral blood flow, as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL), before and after application of intranasal insulin (160 IU)
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive Performance
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brain Perfusion
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Transcranial Doppler (TCD) ultrasound will be used to assess the velocity of blood flow through the middle cerebral artery (MCA)
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Retinal Microvasculature
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Retinal images made by fundus camera
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Systolic Blood Pressure
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Office blood pressure
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Diastolic Blood Pressure
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Office blood pressure
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Heart Rate
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Heart rate measured during office blood pressure measurement
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Circulating Lipids and Lipoproteins
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
High-Density Lipoprotein (HDL) cholesterol, Low-Density Lipoprotein (LDL) cholesterol, Total Cholesterol and Triglycerides will be assessed using clinical chemistry tests
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Circulating Glucose
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Glucose
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Circulating Insulin
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Insulin
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Circulating Markers for Lysosomal Damage
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Markers for lysosomal damage (cathepsin-D and acid-phosphatase)
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Circulating Markers for Liver Health (1)
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Alanine Aminotransferase (ALT) level will be determined using clinical chemistry
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Circulating Markers for Liver Health (2)
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Aspartate Transaminase (AST) level will be determined using clinical chemistry
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Circulating Markers for Liver Health (3)
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Gamma-Glutamyl Transferase (GGT) level will be determined using clinical chemistry
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Circulating Markers for Liver Health (4)
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Bilirubin level will be determined using clinical chemistry
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Circulating Markers for Liver Health (5)
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Cytokeratin-18 (CK-18) level will be determined using clinical chemistry
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Single Nucleotide Polymorphisms (SNPs)
Time Frame: Change in outcomes at baseline before a 16-week skin roasted peanut intervention and 16-week control period.
DNA from leucocytes will be analyzed for the presence of known SNPs in genes encoding proteins known to play a role in cholesterol metabolism.
Change in outcomes at baseline before a 16-week skin roasted peanut intervention and 16-week control period.
Structural Brain Status
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
High-resolution anatomical MPRAGE scan
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Fat Distribution in Abdomen
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Magnetic Resonance Imaging measurements will be included to quantify abdominal fat compartments (i.e. subcutaneous and visceral fat)
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Other perceivable benefits: Quality of Life
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
The Quality of life will be assessed using a 32-item questionnaire
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Other perceivable benefits: Sleep Characteristics
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Other perceivable benefits: Mood
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Mood will be tested using the Affect Grid
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Other perceivable benefits: Stress
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Stress will be assessed using the Perceived Stress Scale (PSS)
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Other perceivable benefits: Physical Fitness (1)
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Timed up-and-go test (TUGT)
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Other perceivable benefits: Physical Fitness (2)
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
The 6-minute walk test (6 MWT)
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Other perceivable benefits: Physical Fitness (3)
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Handgrip test
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Weight
Time Frame: Change in outcomes will be compared at baseline, at 8-weeks and at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Weight in kilograms
Change in outcomes will be compared at baseline, at 8-weeks and at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Waist Circumference
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Waist circumference in centimeters
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Hip Circumference
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Hip circumference in centimeters
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Indirect Fat Distribution
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Measured by skinfold measurements
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Food Intake
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Food intake will be assessed using the Food Frequency Questionnaire
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Fat Content in Liver
Time Frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Magnetic Resonance Imaging measurements will be included to quantify liver fat content
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Peanut Institute Foundation (TPIF)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter J Joris, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • METC 22-046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings