Clinical trial NCT04210869: Mixed Nuts and Brain Vascular Function
Official title: The Long-Term Effects of Mixed Nuts Consumption on Brain Vascular Function in Elderly Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Vascular Function
Cerebral Blood Flow
Keywords: Brain Insulin Sensitivity
Cognitive Performance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: The International Nut and Dried Fruit Council (INC)
First posted: 2019-12-26
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Participants will receive, in random order, daily 60 g of mixed nuts (mixed nut treatment) or no food products (control treatment) for sixteen weeks, separated by a washout 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. The Mediterranean diet, which is rich in nuts, may protect against the development of impaired cognitive performance. The hypothesis is that long-term mixed nut consumption increases brain insulin-sensitivity thereby improving brain vascular function and cognitive performance. The primary objective is to evaluate in elderly men and women the effect of 16-week mixed nut consumption on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to investigate effects on the cerebral blood flow response to intranasal insulin delivery - a marker of insulin-sensitivity in the human brain - as quantified by ASL, and cognitive functioning as assessed with a neuropsychological test battery.


Eligibility criteria: Inclusion Criteria:

* Aged between 60-70 years
* BMI between 25-35 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 nuts
* 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 mixed nuts intervention and 16-week control period.
Secondary outcomes:
measure: Brain Insulin Sensitivity
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Cognitive performance
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
Other outcomes:
measure: Glucose metabolism
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Peripheral vascular function (1)
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Peripheral vascular function (2)
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Peripheral vascular function (3)
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Peripheral vascular function (4)
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Peripheral vascular function (5)
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Blood pressure
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Advanced glycation endproducts
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Blood lipids
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Blood glucose
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Blood insulin
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Blood markers for low-grade systemic inflammation
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Blood markers for microvascular function
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Blood marker of neurogenesis
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Parameters for compliance
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Structural brain status
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Functional connectivity
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Fat distribution in abdomen
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Microbiota composition
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Other perceivable benefits: Quality of Life
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Other perceivable benefits: Sleep characteristics
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Other perceivable benefits: Mood
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Other perceivable benefits: Physical fitness (1)
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Other perceivable benefits: Physical fitness (2)
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Other perceivable benefits: Physical fitness (3)
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Other perceivable benefits: Physical fitness (4)
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Weight
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Length
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Waist circumference
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Hip circumference
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Indirect fat distribution
timeFrame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.
measure: Food intake
timeFrame: Change in outcomes at the end of a 16-week mixed nuts 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: