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NCT Number: NCT07752225

Long-term Effects of Avocado Consumption on Health in Pre-diabetic Individuals

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
  • 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

Exclusion criteria

  • 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
  • Left-handedness
  • Fasting serum total cholesterol > 8.0 mmol/L
  • Current smoker, or smoking cessation < 12 months
  • Abuse of drugs
  • More than 3 alcoholic consumptions per day
  • 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)
  • Blood donation in the 8 weeks before the start of the study
  • Difficulties to draw blood

Treatment and study plan

Avocados

Dietary Supplement

Participants need to consume 1 avocado a day for 12 weeks.

Primary outcomes

  1. Cerebral Blod Flow (CBF)

    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)

Secondary outcomes

  1. Endothelial function (flow mediated dilation)

    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

  2. Endothelial function (carotid artery reactivity)

    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

  3. Aterial stiffness

    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

  4. Cerebral Blood Flow (CBF) in response to intranasal insulin delivery

    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)

  5. Cognitive Performance

    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.

Other outcomes

  1. Bloodoxygen level-dependent (BOLD) functional MRI (fMRI) activity to measure appetite-related brain reward activity

    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.

  2. Peripheral insulin sensitivity

    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)

  3. Mental Health

    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)

  4. Mood

    Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)

    Profile of Mood States (POMS) questionnaire

  5. Stress

    Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)

    Perceived Stress Scale (PSS) questionnaire

  6. Sleep characteristics

    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

  7. Office Blood Pressure

    Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)

    Office blood pressure and heart rate

  8. 24h ambulatory blood pressure

    Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)

    24h ambulatory blood pressure measured every 15 min

  9. Lipid metabolism

    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

  10. Markers related to low-grade systemic inflammation

    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)

  11. Body Composition - Fat Free Mass

    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).

  12. Body Composition - Fat Mass

    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)

  13. 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

  14. Waist circumference

    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

  15. Hip circumference

    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

  16. Food intake

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Tanja Adam, PhD

CONTACT

[email protected]

+31433882123

Tiago Wiesner, MSc

CONTACT

[email protected]

+31433881394

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Avocado Nutrition Center

Registry information

Official study title

Effects of Long-term Avocado Consumption on Brain and Peripheral Cardiovascular Health in Pre-diabetic Individuals

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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