About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women, aged between 40-75 years
Pre-diabetes: (A1C of 5.7%-6.4%, a fasting plasma glucose (FPG) of 100-125 mg/dL, or a 2-hour oral glucose tolerance test (OGTT) result of 140-199 mg/dL)
BMI ³ 25 kg/m2
Fasting serum total cholesterol < 8.0 mmol/L
Disqualifiers
Age less than 40 years old or older than 75 years
BMI < 25 kg/m2
Type 1 or type 2 diabetes
habitual consumption of more than 1 avocado/ week
Trial design
Crossover
Treatments tested in this trial
Avocados
Dietary supplementParticipants need to consume 1 avocado a day for 12 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Cerebral Blod Flow (CBF)
CBF will be non-invasively measured using the gold-standard methodology pseudo-continuous arterial spin labeling magnetic resonance imaging (pCASL MRI)
Secondary outcomes
Endothelial function (flow mediated dilation)
To assess endothelial function changes in diameter during Flow-Mediated Dilation (FMD) of the brachial artery will be measured using ultrasound
Endothelial function (carotid artery reactivity)
Changes in diameter during Carotid Artery Reactivity (CAR) in response to a cold stressor will be assessed using ultrasound
Aterial stiffness
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
Cerebral Blood Flow (CBF) in response to intranasal insulin delivery
CBF will be non-invasively measured using the gold-standard methodology pseudo-continuous arterial spin labeling magnetic resonance imaging (pCASL MRI)
Other outcomes
Bloodoxygen level-dependent (BOLD) functional MRI (fMRI) activity to measure appetite-related brain reward activity
BOLD fMRI activity will be measured before and while participants receive visual stimuli with food or non-food items.
Peripheral insulin sensitivity
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)
Depression
The Beck Depression Inventory (BDI) scores on a 4-point scale (0-3) with a total score between 0 and 63. A higher score suggests more as well as more severe depressive symptoms.
Mood
Profile of Mood States (POMS) questionnaire. The POMS is a 65-item psychological inventory rated on a 5-point Likert scale (0 = Not at all to 4 = Extremely). It entails distinct mood subscales. Subscale scores are summed, and Total Mood Disturbance (TMD) is calculated by adding negative moods and subtracting vigor.
Sponsors and contacts
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Maastricht University Medical Center
Lead sponsor
Avocado Nutrition Center
Collaborator
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