PrediabetesNCT07752225
Long-term Effects of Avocado Consumption on Health in Pre-diabetic Individuals
A study testing Avocados in people with Prediabetes and Brain Insulin Sensitivity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Prediabetes, Brain Insulin Sensitivity, Cerebral Blood Flow
- What is being tested?
- Avocados
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Department of Nutrition and Movement Sciences
Maastricht, Limburg, 6200MD
Tanja Adam, PhD, +31433882123, t.adam@maastrichtuniversity.nl
Tiago Wiesner, MSc, +31433881394, tiago.wiesner@maastrichtuniversity.nl
About this study
Official title: Effects of Long-term Avocado Consumption on Brain and Peripheral Cardiovascular 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.
Read the detailed description
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.
- Conditions
- Prediabetes, Brain Insulin Sensitivity, Cerebral Blood Flow, Satiety and Food Intake, Food Reward, Brain Health
- Being tested
- Avocados
- Keywords
- Avocados, Brain insulin sensitivity, Brain vascular function, Cerebral Blood Flow, CBF, pCASL MRI, CANTAB, Overweight, Obesity, cognitive performance, brain health
- Medical subject headings
- Prediabetic State, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvocadosDietary supplement
Participants need to consume 1 avocado a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Avocado intervention in the first period of the study (Arm 1) | Experimental | Both arms receive the intervention. Arm 1 is consuming 1 or no avocado a day for the first 12 weeks of the study. Receives: Dietary Supplement: Avocados |
| Avocado intervention in the second period of the study (Arm 2) | Experimental | Both arms receive the intervention but arm 2 is consuming 1 or no avocado a day for the last 12 weeks of the study. Receives: Dietary Supplement: Avocados |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: CBF will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Secondary outcomes (5)
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
Measured: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Endothelial function (carotid artery reactivity)
Changes in diameter during Carotid Artery Reactivity (CAR) in response to a cold stressor will be assessed using ultrasound
Measured: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
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
Measured: Wll be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
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)
Measured: This will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Cognitive Performance
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.
Measured: Cognitive parameters will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Avocado Nutrition Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752225
- Sponsor's protocol ID
- METC26-024
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-term Avocado Consumption on Brain and Peripheral Cardiovascular Health in Pre-diabetic Individuals
- ClinicalTrials.gov ID
- NCT07752225
- Acronym / sponsor ID
- METC26-024
- Conditions
- Prediabetes, Brain Insulin Sensitivity, Cerebral Blood Flow, Satiety and Food Intake, Food Reward, Brain Health
- Keywords
- Avocados, Brain insulin sensitivity, Brain vascular function, Cerebral Blood Flow, CBF, pCASL MRI, CANTAB, Overweight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Avocado Nutrition Center
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avocado intervention in the first period of the study (Arm 1) | Experimental | Dietary Supplement: AvocadosBoth arms receive the intervention. Arm 1 is consuming 1 or no avocado a day for the first 12 weeks of the study. |
| Avocado intervention in the second period of the study (Arm 2) | Experimental | Dietary Supplement: AvocadosBoth arms receive the intervention but arm 2 is consuming 1 or no avocado a day for the last 12 weeks of the study. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvocadosParticipants need to consume 1 avocado a day for 12 weeks. | Dietary supplement | Avocado intervention in the first period of the study (Arm 1), Avocado intervention in the second period of the study (Arm 2) |
Primary outcome
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)
5 secondary outcomes
Endothelial function (flow mediated dilation)
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Endothelial function (carotid artery reactivity)
Time frame: Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
Aterial stiffness
Time frame: Wll be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
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)
Cognitive Performance
Time frame: Cognitive parameters will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prediabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avocados in people with Prediabetes and Brain Insulin Sensitivity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanja Adam, PhD (+31433882123, t.adam@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.