Department of Nutrition and Movement Sciences
Maastricht, Limburg, 6200MD, Netherlands
Location contact
Tanja Adam, PhD
CONTACT
Tanja Adam, PhD
PRINCIPAL_INVESTIGATOR
Tiago Wiesner, MSc
CONTACT
NCT Number: NCT07752225
Primary aim of the study is to assess the effect of 12-week daily avocado consumption on cerebral blood flow and markers of cardio- and vascular health in both, the periphery and the brain, in pre-diabetic individuals with overweight or obesity. Secondary objective is to assess the effects of 12-week daily avocado consumption on brain insulin sensitivity after intranasal insulin delivery, vascular function, markers of metabolic health, cognition, and psychological well-being. For that purpose a total of 34 men and women between the ages of 40-75 years old, will participate in a randomised crossover intervention study.
Trial opening soon.
Get Notified40 year–75 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 6200MD, Netherlands
Tanja Adam, PhD
CONTACT
Tanja Adam, PhD
PRINCIPAL_INVESTIGATOR
Tiago Wiesner, MSc
CONTACT
Daily intake of avocado, a food rich in MUFA, PUFA and other essential nutrients such as folate and potassium, has previously been shown to lower systemic markers of cardiovascular risk as well as inflammation in overweight/obese individuals. Especially individuals with cardiovascular disease, or those at an increased risk for cardiovascular disease appear to benefit from regular avocado consumption. In addition to improvements in cardiovascular disease, large cross-sectional studies have linked avocado consumption to a lower risk for metabolic disease, including type 2 diabetes. Despite the beneficial systemic effects observed, the interaction of peripheral cardiovascular risk- and vascular function markers with brain vascular health remains unclear. Furthermore, the clinical implications of this interaction, especially in a population at risk, are unknown.
A total of 34 men and women between the ages of 40-75 years old, with overweight/obesity (BMI: 26-40 kg/m2) will consume a daily avocado (intervention) or no avocado for 12 week in a crossover design.
The primary outcome parameter of the intervention will be cerebral blood flow (CBF). Secondary outcomes include measures for endothelial function (brachial artery flow mediated vasodilation (FMD), carotid artery reactivity (CAR)) and arterial stiffness (pulse wave velocity (PWV), carotid artery distensibility). More cardiometabolic risk markers measured will include office blood pressure, serum lipids, lipoprotein and metabolite profiling, hemostatic factors and plasma biomarkers for low-grade systemic inflammation including IL-6, IL-8, TNF-α, CRP and SAA). Cognitive performance will be assessed in the domains of executive function, memory, psychomotor speed and attention with the Cambridge Neuropsychological Test Automated Battery (CANTAB) as well as the Erikson Flanker test.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants need to consume 1 avocado a day for 12 weeks.
Time frame: CBF will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
CBF will be non-invasively measured using the gold-standard methodology pseudo-continuous arterial spin labeling magnetic resonance imaging (pCASL MRI)
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
To assess endothelial function changes in diameter during Flow-Mediated Dilation (FMD) of the brachial artery will be measured using ultrasound
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Changes in diameter during Carotid Artery Reactivity (CAR) in response to a cold stressor will be assessed using ultrasound
Time frame: Wll be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Pulse Wave Analysis (PWA) of the radial artery and Femoral-to-carotid Pulse Wave Velocity (PWV) in m/s will be measured with a tonometer using Sphygomocor
Time frame: This will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
CBF will be non-invasively measured using the gold-standard methodology pseudo-continuous arterial spin labeling magnetic resonance imaging (pCASL MRI)
Time frame: CBF will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Cognitive performance measurement of the following cognitive domains: memory, executive function and psychomotor speed. Measurements will be performed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) and the Flanker test.
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
BOLD fMRI activity will be measured before and while participants receive visual stimuli with food or non-food items.
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
7-point oral glucose tolerance test (OGTT) to determine insulin sensitivity based on insulin and glucose concentrations, Matsuda index and 2h glucose tolerance (2h glucose concentrations)
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Beck Depression Inventory (BDI), State-Trait Anxiety Inventories (STAI)
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Profile of Mood States (POMS) questionnaire
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Perceived Stress Scale (PSS) questionnaire
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Pittsburgh Sleep Quality Index (PSQI) questionnaire to assess sleep duration, quality, latency, and efficiency
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Office blood pressure and heart rate
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
24h ambulatory blood pressure measured every 15 min
Time frame: Will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Circulating triacylglycerol, High-Density Lipoprotein (HDL) cholesterol, Low-Density Lipoprotein (LDL) cholesterol, and Total Cholesterol concentrations
Time frame: Will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Interleukin (IL)-1β, IL-6, IL-8, tumor necrosis factor (TNF)a, monocyte chemo attractant protein (MCP)-1, C-reactive protein (hsCRP) and serum amyloid A (SAA)
Time frame: Will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
BodPod will be used to measure fat free mass (weight).
Time frame: Will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
BodPod will be used to measure fat mass (weight)
Time frame: Will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Weight in kilograms
Time frame: Will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Waist circumference in centimeters
Time frame: Will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Hip circumference in centimeters
Time frame: Will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Food intake will be assessed using the Food Frequency Questionnaire
Contact information is provided by the study sponsor or research team.
Tanja Adam, PhD
CONTACT
Tiago Wiesner, MSc
CONTACT
Maastricht University Medical Center
Other
Effects of Long-term Avocado Consumption on Brain and Peripheral Cardiovascular Health in Pre-diabetic Individuals
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