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| Name | Class |
|---|---|
| The Peanut Institute Foundation (TPIF) | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Skin roasted peanuts |
|
| Control | No Intervention | No skin roasted peanuts |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin roasted peanuts | Dietary Supplement | Study volunteers will receive daily 60 g of skin roasted peanuts for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain Vascular Function | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Performance | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Perfusion | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Joris, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41205298 | Derived | Kerkhof L, Mensink RP, Plat J, Nijssen KMR, Joris PJ. Longer-term skin-roasted peanut consumption improves brain vascular function and memory: A randomized, single-blind, controlled crossover trial in healthy older adults. Clin Nutr. 2025 Dec;55:170-179. doi: 10.1016/j.clnu.2025.10.020. Epub 2025 Nov 1. |
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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.
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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 | 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 | Office blood pressure | Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period. |
| Heart Rate | 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 | 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 | Glucose | Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period. |
| Circulating Insulin | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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. |
| Fat Content in Liver | 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. |
| Other perceivable benefits: Quality of Life | 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 | 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 | 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 | 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) | 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) | 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) | Handgrip test | Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period. |
| Weight | 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 | 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 | 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 | 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 | 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. |