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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorMaastricht University Medical Center

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Avocados

    Dietary supplement

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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Avocado intervention in the first period of the study (Arm 1)Experimental treatment 1 intervention
Group B: Avocado intervention in the second period of the study (Arm 2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
CBF will be assessed at baseline, after period 1 (after 12 weeks), and at the end of the study (after 32 weeks)

Secondary outcomes

1

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

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

Endothelial function (carotid artery reactivity)

Changes in diameter during Carotid Artery Reactivity (CAR) in response to a cold stressor will be assessed using ultrasound

Time frame
Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
3

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

Time frame
Wll be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
4

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)

Time frame
This will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)

Other outcomes

1

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.

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

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)

Time frame
Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
3

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.

Time frame
Will be assessed after period 1 (12 weeks) and after period 2 (32 weeks)
4

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.

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

Sponsors and contacts

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Maastricht University Medical Center

Lead sponsor

Avocado Nutrition Center

Collaborator

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