Clinical trial NCT05724654: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brain Vascular Function
Cerebral Blood Flow
Brain Insulin Sensitivity
Cognitive Performance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: The Peanut Institute Foundation (TPIF)
First posted: 2023-02-13
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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


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)

Primary outcomes:
measure: Brain Vascular Function
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Brain Insulin Sensitivity
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Secondary outcomes:
measure: Cognitive Performance
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Other outcomes:
measure: Brain Perfusion
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Retinal Microvasculature
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Systolic Blood Pressure
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Diastolic Blood Pressure
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Heart Rate
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Circulating Lipids and Lipoproteins
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Circulating Glucose
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Circulating Insulin
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Circulating Markers for Lysosomal Damage
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Circulating Markers for Liver Health (1)
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Circulating Markers for Liver Health (2)
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Circulating Markers for Liver Health (3)
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Circulating Markers for Liver Health (4)
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Circulating Markers for Liver Health (5)
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Single Nucleotide Polymorphisms (SNPs)
timeFrame: Change in outcomes at baseline before a 16-week skin roasted peanut intervention and 16-week control period.
measure: Structural Brain Status
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Fat Distribution in Abdomen
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Fat Content in Liver
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Other perceivable benefits: Quality of Life
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Other perceivable benefits: Sleep Characteristics
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Other perceivable benefits: Mood
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Other perceivable benefits: Stress
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Other perceivable benefits: Physical Fitness (1)
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Other perceivable benefits: Physical Fitness (2)
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Other perceivable benefits: Physical Fitness (3)
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Weight
timeFrame: 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.
measure: Waist Circumference
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Hip Circumference
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Indirect Fat Distribution
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
measure: Food Intake
timeFrame: Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Peter J Joris, PhD
role: PRINCIPAL_INVESTIGATOR
References: