Avocado Diet Study for Prediabetes and Insulin Resistance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will randomly assign 40-70 year-old adults with elevated triglycerides and insulin resistance to either an avocado-rich meal plan or a control meal plan for four weeks. Participants will consume most of their meals through the provided plans and attend up to six clinic visits at IIT’s CNRC to monitor metabolic outcomes. The study follows Good Clinical Practice and uses objective blood tests to assess triglycerides, glucose, and insulin responses. Eligibility includes specific lipid and insulin criteria, and participants must avoid alcohol and strenuous activity around visits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men or women, 40-70 years of age.
* Fasting triglycerides (TG) \>115 mg/dL.
* Insulin resistance as measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \>2.5.
* Able to provide informed consent.
* Able to comply with and perform the procedures requested by the protocol, specifically eat all the meals and snacks provided by the study which will be almost all your food (\~ 80% of calories per day).
* Able to come to the clinic up to 6 times during the study.
* Able to maintain usual physical activity pattern.
* Able to avoid/abstain from alcohol and vigorous physical activity for 24 hours prior to and during study visit.

Exclusion Criteria:

* Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions.
* Fasting blood sugar ≥125 mg/dL. Men and women with blood pressure \>160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit.
* Men and women with history of diabetes cardiovascular events, respiratory, renal, gastrointestinal, hepatic or eye disease or surgery- within a year.
* Men and women who have or had cancer other than non-melanoma skin cancer in the past 5 years.
* Men and women taking over the counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints.
* Men and women who are on a specialized diet (vegan, vegetarian, keto, etc.). - - Men and women who consume nuts or peanuts daily or most days of the week.
* Men and women who are not weight stable (+/-10lbs in previous 2 months). Men and women who have excessive use of drugs or alcohol (ie., addictions) within the past 2 years.
* Men and women with documented physical or mental disease/condition, which might limit participation in or completion of the study or, that, in the opinion of the investigator, could interfere with the interpretation of the study results.
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study.
* Women who are lactating.
* Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI. Has used antibiotics within the previous 2 months.
* History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
* Excessive coffee and tea consumers (\> 4 cups/d).
* Donated blood within the last 3 months.
* Women who are taking an unstable dose and brand of hormonal contraceptives and/or a stable dose and brand for less than 6 months.
* Unusual working hours (working overnight).

Where it's running

• Clinical Nutrition Research Center at IIT
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Britt Burton-Freeman, PhD — Food Sci and Nut Programs
• Study coordinator: Chelsea Preiss, MS
• Email: cpreiss@illinoistech.edu
• Phone: 312-567-5300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.