Avocado for Type 2 Diabetes

(AVOCADO-T2D Trial)

Overseen By Rob Leonard

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Thiazolidinediones, High-dose diuretics

Disqualifiers: Type 1 diabetes, Renal insufficiency, Unstable heart disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if eating Hass avocados can help control blood sugar in people with Type 2 diabetes. Participants will consume either one avocado a day or a similar amount of other fruits to compare effects on fasting blood sugar levels. The trial seeks individuals with Type 2 diabetes, a stable medication routine, a body mass index (BMI) between 27 and 50, and a willingness to follow study protocols, including blood tests. As an unphased trial, it offers a unique opportunity to contribute to research that could lead to new dietary recommendations for managing Type 2 diabetes.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. However, you must be on a stable regimen of all medications, including diabetes medications, for at least 3 months before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that eating avocados is generally safe and may benefit health. One study found that people who eat avocados tend to have healthier diets and better control of their blood sugar levels. Another study found that avocado eaters have a lower risk of developing diabetes.

These studies did not report any serious safety concerns about eating avocados, suggesting they are easy to digest and safe to include in a diet. However, it's always wise to consider any personal allergies or dietary restrictions before adding something new to one's diet. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for Type 2 Diabetes, which often include medications like metformin or insulin to manage blood sugar levels, the avocado treatment is unique because it uses a natural food source. Avocados are rich in healthy fats and fibers, which can help in stabilizing blood sugar levels and improving overall metabolic health. Researchers are excited about this approach because it offers a potentially safer and more holistic way to manage diabetes, with the added benefits of nutrients that support heart health and weight management. Plus, incorporating a tasty fruit like avocado into the diet might improve patient adherence compared to traditional medication regimens.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that eating avocados is linked to a lower risk of developing diabetes. Studies suggest that avocados can help control blood sugar levels more effectively. Avocatin B, an important component of avocados, helps manage diabetes. Although more research is needed to confirm these effects specifically for Type 2 Diabetes, current findings are promising. In this trial, participants will consume either one Hass avocado a day or other fruits to compare their effects on managing Type 2 Diabetes. ^{3 4 6 7 8}

Who Is on the Research Team?

John W Apolzan, PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with Type 2 diabetes, a BMI of 27-50, and stable blood sugar control medication. Participants must not be pregnant or trying to conceive, have recent major surgery, unstable heart disease, severe kidney issues, or be on weight loss drugs. They should agree to consume avocados and follow the study protocol.

Inclusion Criteria

Your body mass index (BMI) is between 27 and 50.

Your HbA1c level is between 5.7% and 11%, or your fasting blood glucose is 100 mg/dL or higher.

My medication, including for diabetes, has been stable for 3 months.

Exclusion Criteria

My blood pressure is higher than 180/100 mm Hg.

You have a mental illness, memory problems, or drug/alcohol problems that might make it hard for you to follow the study instructions.

You drink more than 14 alcoholic drinks per week and don't want to stop drinking during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 1 Hass avocado a day or other fruits for glycemic control

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Avocado
• Other Fruit(s)

Trial Overview

The study aims to see if eating Hass Avocados can improve blood sugar levels in people with Type 2 diabetes compared to consuming an equal calorie amount of other fruits during controlled feeding conditions.

How Is the Trial Designed?

Group I: Avocado Experimental Treatment 1 Intervention

Participants will consume 1 Hass avocado a day.

Group II: Other Fruit(s) Active Control 1 Intervention

Participants in the other fruit arm will receive other fruits.

Avocado is already approved in Canada, United States for the following indications:

Approved in Canada as Avocado for:

• None specifically approved; however, components like Avocatin B are under investigation for diabetes management

Approved in United States as Avocado for:

• None specifically approved; however, components like Avocatin B are under investigation for diabetes management

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

Prachi Singh

Collaborator

Trials

2

Recruited

70+

Frank L. Greenway

Collaborator

Trials

4

Recruited

110+

Robbie A. Beyl

Collaborator

Trials

3

Recruited

100+

Published Research Related to This Trial

A systematic review of 16 clinical studies found that consuming edible plants from the Alliaceae and Brassicaceae families significantly reduced fasting blood glucose levels in patients with type 2 diabetes, with an average reduction of 12.67 mg/dl compared to placebo.

These plants not only lowered blood glucose levels but also enhanced the effectiveness of standard antidiabetic therapies, indicating their potential as a safe and well-tolerated addition to diabetes management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential effects of Alliaceae and Brassicaceae edible plants on blood glucose levels in patients with type 2 diabetes: A systematic review and meta-analysis of clinical trials. Piragine, E., Petri, D., Giometto, S., et al.[2022]

A high-fiber, low-fat diet primarily from plant sources, combined with support, significantly reduced A1C levels in Latinos with type 2 diabetes, showing a mean decrease from 8.53 to 7.31 in the experimental group over 6 months.

The study involved 32 participants from medically underserved areas, and the experimental group had a statistically significant improvement in diabetes management compared to the control group, indicating the effectiveness of dietary intervention and support in self-management of diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Plant-Based Diet and Support on Mitigating Type 2 Diabetes Mellitus in Latinos Living in Medically Underserved Areas. Ramal, E., Champlin, A., Bahjri, K.[2022]

In a study involving 12,403 cases of type 2 diabetes (T2D) from a cohort of 340,234 people across eight European countries, the consumption of cakes and cookies was found to be inversely related to T2D risk, suggesting that moderate intake may not be harmful.

Overall, fatty foods like vegetable oil, butter, and nuts and seeds showed no significant association with T2D risk, while higher margarine consumption was weakly linked to increased risk after adjusting for body mass index (BMI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of fatty foods and incident type 2 diabetes in populations from eight European countries. Buijsse, B., Boeing, H., Drogan, D., et al.[2022]

A review of current research indicates that diets high in plant foods, particularly those rich in flavonoids like anthocyanins and flavan-3-ols, can significantly reduce the risk of developing type 2 diabetes mellitus (T2DM).

Flavonoids may help lower T2DM risk by improving glucose absorption and enhancing insulin sensitivity and secretion, highlighting the importance of dietary choices in managing diabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Selective Role of Dietary Anthocyanins and Flavan-3-ols in Reducing the Risk of Type 2 Diabetes Mellitus: A Review of Recent Evidence. Burton-Freeman, B., Brzeziński, M., Park, E., et al.[2023]

A case-control study involving 384 patients with type 2 diabetes and 768 controls found that lower intakes of fruits and whole grains were associated with a higher risk of T2DM.

The study identified that higher consumption of fruits and whole grains significantly reduced the risk of T2DM, with adjusted odds ratios indicating a strong protective effect, especially for those following a high-fruit dietary pattern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A diet rich in fruit and whole grains is associated with a low risk of type 2 diabetes mellitus: findings from a case-control study in South China. Ye, Y., Zhuo, S., Lu, W., et al.[2023]

In a study involving over 63,000 women and 21,000 men, the consumption of soy foods like tofu and soy milk did not show a significant association with a reduced risk of type 2 diabetes (T2D).

However, higher intake of isoflavones, compounds found in soy, was linked to a modestly lower risk of T2D, suggesting that while soy foods alone may not be protective, the isoflavones they contain could contribute to diabetes risk reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of soy foods and isoflavones and risk of type 2 diabetes: a pooled analysis of three US cohorts. Ding, M., Pan, A., Manson, JE., et al.[2022]

A 28-day treatment with aqueous, ethanolic, and methanolic leaf extracts of avocado significantly reduced blood glucose levels in type 2 diabetic rats, with the methanolic extract showing the most pronounced effect.

The methanolic extract not only improved glucose homeostasis but also promoted regeneration of pancreatic islets and was well tolerated, indicating its potential as a natural treatment for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Antidiabetic Activity of Aqueous, Ethanol, and Methanol Leaf Extracts of Persea americana and Their Effectiveness in Type 2 Diabetic Rats. Kouamé, NM., Koffi, C., N'Zoué, KS., et al.[2020]

Avocado Seed Glycosides (ASG) demonstrated significant vasoprotective properties in rats with Diabetes-Induced Vascular Damage (DIVD), normalizing levels of harmful substances like VCAM-1 and LDL-c after 28 days of treatment.

While ASG did not significantly impact glucose homeostasis compared to standard anti-diabetic drugs, it effectively normalized other vascular damage markers, suggesting potential therapeutic benefits beyond blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular Effects of Avocado Seed Glycosides during Diabetes-induced Endothelial Damage. Amadi, PU., Agomuo, EN., Adumekwe, C.[2021]

A 3-month produce prescription program for 303 predominantly Hispanic/Latino adults with or at risk of type 2 diabetes led to significant reductions in weight, waist circumference, and systolic blood pressure, indicating improved cardio-metabolic health.

Participants with higher baseline HbA1c levels experienced a notable decrease in HbA1c, alongside improvements in food security and mental health measures, suggesting that access to fresh produce can positively impact both physical and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal changes in bio-behavioral and glycemic outcomes following a produce prescription program among predominantly Hispanic/Latino adults with or at risk of type 2 diabetes. Sato Imuro, SE., Sabharwal, A., Conneely, C., et al.[2023]

Citations

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sciencedirect.com

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Association Between Avocado Consumption and Diabetes ...

Avocado consumption was associated with a lower risk of diabetes, which remained significant even when adjusted for relevant covariates.

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jebms.org/full-text/126

Avocatin B: Its Role in Cancer and Diabetes Mellitus ...

Avocatin B (AvoB), a lipid derived from avocado, has been shown to be an inhibitor of FAO, which accumulates in mitochondria to induce leukemia cell apoptosis.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10489295/

Associations between Avocado Intake and Lower Rates of ...

Data suggest that avocado intake is associated with better glycemic control, but whether this translates to protection from T2D has not been studied.

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withpower.com

withpower.com/trial/phase-diabetes-mellitus-6-2023-649ec

Avocado for Type 2 Diabetes (AVOCADO-T2D Trial)

This trial is testing if eating Hass Avocados can help lower blood sugar levels. The study focuses on people who need to manage their blood sugar.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8705026/

A Comprehensive Review of Hass Avocado Clinical Trials ...

Hass avocados appear to be most effective in lowering blood lipids in diets with up to about 50% energy from carbohydrates. In a randomized ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3664913/

Hass Avocado Composition and Potential Health Effects - PMC

Several preclinical studies suggest that avocado components may protect skin health by enhancing wound healing activity and reducing UV damage (Nayak et al., ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9486596/

Avocado Consumption for 12 Weeks and Cardiometabolic ...

Avocado intake was associated with a healthier dietary pattern and trends favoring improved glucose control and reduced biomarkers of cardiometabolic risk.

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Avocatin B: Its Role in Cancer and Diabetes Mellitus ...

[59]. According to data from various studies, consumption of ≥1 serving of avocado per week was associated with reduced total risk.[68] AvoB, a ...