Food and Metabolism Study

NCT07624500 | Not Yet Recruiting

• 1 other identifier: IRB-2026-34
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we are interested in looking at the influence of eating avocados regularly, which are rich in healthy fats, fibers, and unique carbohydrates, on triglyceride and glucose metabolism in people with prediabetes and insulin resistance.

Conditions

Prediabetes; Insulin Resistance; Lipids Metabolism; Triglycerides

Keywords

Triglycerides; Insulin resistance; Glucose metabolism; Lipids metabolism

Outcome Measures

Primary Outcomes (1)

• Changes in serum biomarker: triglycerides

  analyzed by McLendon labs

  baseline and 4 weeks

Secondary Outcomes (13)

• Changes in serum biomarker: insulin

  baseline and 4 weeks

• Changes in serum biomarker: glucose

  baseline and 4 weeks

• Changes in HOMA-IR

  baseline and 4 weeks

• Changes in Muscle Insulin Sensitivity Index (MISI)

  baseline and 4 weeks

• Changes in total cholesterol

  baseline and 4 weeks

Study Arms (2)

Avocado meal plan

ACTIVE COMPARATOR

2 meals and snack per day including one avocado in the meal, covering 80% of daily calories need.

Other: Avocado meal plan

Control meal plan

PLACEBO COMPARATOR

2 meals and snacks per day without the inclusion of avocado, covering 80% of daily calories needs.

Other: Control meal plan

Interventions

Avocado meal plan OTHER

American Diet with avocado

Avocado meal plan

Control meal plan OTHER

American diet

Control meal plan

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women, 40-70 years of age.
• Fasting triglycerides (TG) \>115 mg/dL.
• Insulin resistance as measured by 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• Hass Avocado Board: collaborator

Study Sites (1)

Clinical Nutrition Research Center at IIT

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Britt Burton-Freeman, PhD

  Food Sci and Nut Programs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsea Preiss, MS

CONTACT

312-567-5300; cpreiss@illinoistech.edu

Indika Edirisinghe, PhD

CONTACT

708-563-8178; iedirisi@illinoistech.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

US (1)