What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes that focus on nutritional components like fiber, healthy fats, and low carbohydrate content include high-fiber diets, consumption of healthy fats (e.g., from avocados, nuts, and certain oils), and low-carbohydrate diets. High-fiber diets can lead to gastrointestinal issues such as bloating and gas. Healthy fats are generally well-tolerated but can contribute to weight gain if consumed in excess. Low-carbohydrate diets may cause initial side effects like headaches, fatigue, and irritability as the body adjusts to lower carbohydrate intake. Long-term adherence to these diets can be challenging for some individuals.

What prior FDA approvals exist?

The FDA has approved various treatments for Type 2 Diabetes that focus on different mechanisms to control blood sugar levels. While specific approvals for nutritional components like those found in Hass Avocados (fiber, healthy fats, and low carbohydrate content) are not detailed, dietary management is a recognized approach. For instance, medical nutrition therapy, which includes dietary adjustments to improve glycemic control, is a recommended strategy. Additionally, drugs like metformin, which improve insulin sensitivity, and GLP-1 receptor agonists, which can aid in weight loss and glycemic control, are commonly used. These treatments, combined with lifestyle modifications, form a comprehensive approach to managing Type 2 Diabetes.

What other types of research exist?

Promising alternatives to Hass Avocados for Type 2 Diabetes patients include: 1) Nuts such as almonds and walnuts, which are rich in healthy fats and fiber. 2) Chia seeds and flaxseeds, which provide omega-3 fatty acids and fiber. 3) Leafy greens like spinach and kale, which are low in carbohydrates and high in fiber. 4) Berries such as blueberries and strawberries, which have a low glycemic index and are high in fiber. These alternatives can help stabilize blood sugar levels and provide essential nutrients.

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Avocado for Type 2 Diabetes (AVOCADO-T2D Trial)

N/A

Recruiting

Led By John W Apolzan, PhD

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant reported diagnosis of Type 2 diabetes

Age range - 18 - 65 years (inclusive)

Must not have

History of a surgical procedure for weight loss in last 5 years (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)

Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a non-hemolyzed specimen, or a creatinine over 2.5 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 5 - week 0

Awards & highlights

No Placebo-Only Group

Summary

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. Researchers think that Hass Avocados might be better at reducing blood sugar than other fruits with the same number of calories. Avocado oil has been shown to improve glucose tolerance and reduce insulin resistance in animal studies.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While avocados are generally safe and nutritious, some individuals might experience mild digestive discomfort or allergic reactions when consuming them as part of their diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Type 2 diabetes.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had weight loss surgery in the last 5 years.

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My kidney function is impaired with high potassium or creatinine levels.

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I have not had major surgery in the last three months.

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I am willing and able to eat avocados as required by the study.

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I am not pregnant, breastfeeding, trying to conceive, and I use effective birth control.

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I am taking high doses of water pills (like furosemide 40mg or more).

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My bilirubin is over 3 mg/dL or my albumin is less than 3 g/dL.

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I do not have uncontrolled stomach or bowel disorders.

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I have diabetes and take insulin or specific diabetes medications.

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I do not have ongoing heart problems like unstable angina.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 5 - week 0

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 5 - week 0

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 5 - week 0 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fasting Blood Glucose

Secondary study objectives

Fasting Insulin

Fructosamine

Glycated Albumin

Other study objectives

Blood Glucose

Glucose

Insulin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AvocadoExperimental Treatment1 Intervention

Participants will consume 1 Hass avocado a day.

Group II: Other Fruit(s)Active Control1 Intervention

Participants in the other fruit arm will receive other fruits.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include medications like metformin, which reduces glucose production in the liver and improves insulin sensitivity, and lifestyle interventions such as diet and exercise. Nutritional components like those found in Hass Avocados—fiber, healthy fats, and low carbohydrate content—play a crucial role in stabilizing blood sugar levels. Fiber slows glucose absorption, healthy fats improve insulin sensitivity, and low carbohydrate content reduces blood sugar spikes. These mechanisms are vital for Type 2 Diabetes patients as they help maintain better glycemic control, reduce the risk of complications, and improve overall metabolic health.

The Effects of Almonds on Gut Microbiota, Glycometabolism, and Inflammatory Markers in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.Oligomeric Proanthocyanidin Complex from Avocado Seed as A Promising α-glucosidase Inhibitor: Characteristics and Mechanisms.Comparative Antidiabetic Activity of Aqueous, Ethanol, and Methanol Leaf Extracts of Persea americana and Their Effectiveness in Type 2 Diabetic Rats.