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Effects of Peanut Consumption on Brain Function

Primary Purpose

Brain Vascular Function, Cerebral Blood Flow, Brain Insulin Sensitivity

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Skin roasted peanuts
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Vascular Function

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Maastricht University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Skin roasted peanuts

No skin roasted peanuts

Outcomes

Primary Outcome Measures

Brain Vascular Function
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Brain Insulin Sensitivity
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)

Secondary Outcome Measures

Cognitive Performance
Cambridge Neuropsychological Test Automated Battery (CANTAB)

Full Information

First Posted
January 11, 2023
Last Updated
June 29, 2023
Sponsor
Maastricht University Medical Center
Collaborators
The Peanut Institute Foundation (TPIF)
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1. Study Identification

Unique Protocol Identification Number
NCT05724654
Brief Title
Effects of Peanut Consumption on Brain Function
Official Title
Longer-term Effects of Peanut Consumption on Brain Function in Older Men and Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
The Peanut Institute Foundation (TPIF)

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
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 non-invasively quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Vascular Function, Cerebral Blood Flow, Brain Insulin Sensitivity, Cognitive Performance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Study participants will receive in random order daily 60 g of skin roasted peanuts (peanut intervention) or no peanuts for a total of 16 weeks (control intervention), separated by a wash-out period of at least 8 weeks.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Skin roasted peanuts
Arm Title
Control
Arm Type
No Intervention
Arm Description
No skin roasted peanuts
Intervention Type
Dietary Supplement
Intervention Name(s)
Skin roasted peanuts
Intervention Description
Study volunteers will receive daily 60 g of skin roasted peanuts for 16 weeks.
Primary Outcome Measure Information:
Title
Brain Vascular Function
Description
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Brain Insulin Sensitivity
Description
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)
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Secondary Outcome Measure Information:
Title
Cognitive Performance
Description
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Other Pre-specified Outcome Measures:
Title
Brain Perfusion
Description
Transcranial Doppler (TCD) ultrasound will be used to assess the velocity of blood flow through the middle cerebral artery (MCA)
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Retinal Microvasculature
Description
Retinal images made by fundus camera
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Systolic Blood Pressure
Description
Office blood pressure
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Diastolic Blood Pressure
Description
Office blood pressure
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Heart Rate
Description
Heart rate measured during office blood pressure measurement
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Circulating Lipids and Lipoproteins
Description
High-Density Lipoprotein (HDL) cholesterol, Low-Density Lipoprotein (LDL) cholesterol, Total Cholesterol and Triglycerides will be assessed using clinical chemistry tests
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Circulating Glucose
Description
Glucose
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Circulating Insulin
Description
Insulin
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Circulating Markers for Lysosomal Damage
Description
Markers for lysosomal damage (cathepsin-D and acid-phosphatase)
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Circulating Markers for Liver Health (1)
Description
Alanine Aminotransferase (ALT) level will be determined using clinical chemistry
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Circulating Markers for Liver Health (2)
Description
Aspartate Transaminase (AST) level will be determined using clinical chemistry
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Circulating Markers for Liver Health (3)
Description
Gamma-Glutamyl Transferase (GGT) level will be determined using clinical chemistry
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Circulating Markers for Liver Health (4)
Description
Bilirubin level will be determined using clinical chemistry
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Circulating Markers for Liver Health (5)
Description
Cytokeratin-18 (CK-18) level will be determined using clinical chemistry
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Single Nucleotide Polymorphisms (SNPs)
Description
DNA from leucocytes will be analyzed for the presence of known SNPs in genes encoding proteins known to play a role in cholesterol metabolism.
Time Frame
Change in outcomes at baseline before a 16-week skin roasted peanut intervention and 16-week control period.
Title
Structural Brain Status
Description
High-resolution anatomical MPRAGE scan
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Fat Distribution in Abdomen
Description
Magnetic Resonance Imaging measurements will be included to quantify abdominal fat compartments (i.e. subcutaneous and visceral fat)
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Fat Content in Liver
Description
Magnetic Resonance Imaging measurements will be included to quantify liver fat content
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Other perceivable benefits: Quality of Life
Description
The Quality of life will be assessed using a 32-item questionnaire
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Other perceivable benefits: Sleep Characteristics
Description
Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Other perceivable benefits: Mood
Description
Mood will be tested using the Affect Grid
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Other perceivable benefits: Stress
Description
Stress will be assessed using the Perceived Stress Scale (PSS)
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Other perceivable benefits: Physical Fitness (1)
Description
Timed up-and-go test (TUGT)
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Other perceivable benefits: Physical Fitness (2)
Description
The 6-minute walk test (6 MWT)
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Other perceivable benefits: Physical Fitness (3)
Description
Handgrip test
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Weight
Description
Weight in kilograms
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.
Title
Waist Circumference
Description
Waist circumference in centimeters
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Hip Circumference
Description
Hip circumference in centimeters
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Indirect Fat Distribution
Description
Measured by skinfold measurements
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Title
Food Intake
Description
Food intake will be assessed using the Food Frequency Questionnaire
Time Frame
Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Kerkhof, MSc
Phone
+31 433881313
Email
l.kerkhof@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Peter J Joris, PhD
Phone
+31 433881311
Email
p.joris@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Joris, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter J Joris, PhD
Phone
+31 433881311
Email
p.joris@maastrichtuniversity.nl

12. IPD Sharing Statement

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Effects of Peanut Consumption on Brain Function

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