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Completed

NCT Number: NCT05724654

Effects of Peanut Consumption on Brain Function

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).

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Skin roasted peanuts

Dietary Supplement

Study volunteers will receive daily 60 g of skin roasted peanuts for 16 weeks.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Circulating Glucose

    Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

    Glucose

  8. Circulating Insulin

    Time frame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

    Insulin

  9. 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)

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  16. 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

  17. 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)

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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)

  23. 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)

  24. 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)

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • The Peanut Institute Foundation (TPIF)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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