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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Compare the effects of three evening snacks on morning fasting and postprandial glucose and insulin concentrations in individuals with prediabetes.

Research Team

Britt Burton-Freeman, ph.D

Principal Investigator

Illinois Institute of Technology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+