Avocado Snacks for Prediabetes

(AVOC4 Trial)

Overseen By indika Edirisinghe, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology

Must not be taking: Lipid-lowering, Anti-inflammatory, Antioxidants, others

Disqualifiers: Diabetes, Cancer, Cardiovascular, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2-3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different evening snacks affect morning blood sugar and insulin levels in people with prediabetes. Participants will try one of three snacks: an avocado (a fruit known for its healthy fats), a high-fat and high-fiber control, or a low-fat and low-fiber control. The trial is suitable for non-smokers with prediabetes, defined by fasting blood sugar levels between 100 and 125 mg/dL, who can adhere to a specific dietary plan and attend study visits. As an unphased trial, it offers a unique opportunity to contribute to understanding dietary impacts on prediabetes.

Do I need to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications or supplements that could interfere with the study, like lipid-lowering or anti-inflammatory drugs. If you're taking dietary supplements, you might need a 30-day period without them before starting the trial.

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

Research shows that eating avocados is generally safe for most people. Studies have found that adding avocados to the diet can help control blood sugar levels, potentially lowering the risk of developing diabetes. No strong evidence of serious side effects from eating avocados exists, suggesting they are well-tolerated.

For those considering joining a trial involving avocados, current research suggests they are safe to eat and may offer health benefits without major risks. However, consulting a healthcare professional is advisable if there are any concerns before trying something new. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the usual medications for prediabetes, which often include lifestyle changes and drugs like metformin to manage blood sugar levels, the avocado snack treatment takes a fresh approach. Researchers are excited because avocados are packed with healthy fats and fibers that might help regulate blood sugar naturally. This treatment is unique because it uses a whole food—avocado—as the active ingredient, which could offer a more natural way to support metabolic health. Plus, incorporating avocados could be an easier and more enjoyable dietary change for many people compared to traditional medications.

What evidence suggests that this trial's treatments could be effective for prediabetes?

Research has shown that eating avocados might help control blood sugar. In one study, adults with insulin resistance who ate avocados for 12 weeks had improved blood sugar levels, as measured by their HbA1c, a common blood sugar test. Another study found that people who regularly eat avocados have a lower risk of developing diabetes. In this trial, participants will receive either an avocado snack or a control snack. These findings suggest that avocados could be a beneficial snack choice for people with prediabetes, possibly helping to manage their blood sugar levels. ^{2 3 6 7 8}

Who Is on the Research Team?

Britt Burton-Freeman, ph.D

Principal Investigator

Illinois Institute of Technology

Are You a Good Fit for This Trial?

This trial is for men and women aged 25-70 with prediabetes, defined as fasting blood glucose between 100-125 mg/dL. Participants should be nonsmokers in good health without cardiovascular or metabolic diseases, not on interfering medications, and able to follow the study's diet and testing protocols.

Inclusion Criteria

Men or women, age 25-70 years

Able to comply and perform the procedures requested by the protocol (follow the dietary plans, come to scheduled visits, record food intake in a diary, complete questionnaires, provide blood samples and complete other tests (eye and brain/cognitive function))

Fasting blood glucose concentration between 100 mg/dL and 125 mg/dL at screening visit

Exclusion Criteria

Both men and women with diabetes.

You have had any type of cancer, except for non-melanoma skin cancer, within the past 5 years.

Women who are lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 hours

1 visit (in-person)

Treatment

Participants receive different evening snacks in a randomized order before each Study Day visit

2-3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Avocado
• low fat yogurt
• low fat yogurt + fiber +fat

Trial Overview The study compares three evening snacks: low-fat yogurt; avocado; and a combination of low-fat yogurt with added fiber and fat. It aims to observe their effects on morning fasting glucose levels as well as post-meal insulin concentrations in prediabetic individuals.

How Is the Trial Designed?

Group I: control snack Experimental Treatment 1 Intervention

Low-fiber, low-fat

Group II: Avocado snack Experimental Treatment 1 Intervention

1 avocado

Group III: control snack + fiber supplement + vegetable oil Placebo Group 1 Intervention

high fat, high fiber control

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?

Clinical Nutrition Research Center, Illinois Institute of Technology

Lead Sponsor

Trials

55

Recruited

3,000+

Hass Avocado Board

Collaborator

Trials

13

Recruited

760+

Citations

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

Avocado Consumption for 12 Weeks and Cardiometabolic ... In conclusion, avocado intake for 12 wk showed beneficial effects on glucose control suggested by the HbA1c results in adults with OW/OB and insulin resistance.

2. 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.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212267224001928

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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05263011?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Clinical%20Nutrition%20Research%20Center,%20Illinois%20Institute%20of%20Technology%22)&viewType=Table&rank=7

Avocado Snacks in a Prediabetic Population (AVOC4) Compare the effects of three evening snacks on morning fasting and postprandial glucose and insulin concentrations in individuals with prediabetes. Detailed ...

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

Avocado for Type 2 Diabetes (AVOCADO-T2D Trial) A 28-day treatment with aqueous, ethanolic, and methanolic leaf extracts of avocado significantly reduced blood glucose levels in type 2 diabetic rats, with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10842938/

Associations between avocado intake and measures of ... Despite a lack of associations in adults with prediabetes, the results here suggest that a diet containing avocado is associated with better glucose homeostasis ...

7. 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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06818032

NCT06818032 | Avocado and Postprandial Responses The purpose of this study is to see how adding avocado to a breakfast meal affects blood sugar control and signals of hunger and fullness after eating.