Clinical trial Recruiting at 1 site Interventional Ages 21 to 74

Replacing refined-carb foods with avocado to test inflammation markers

Official title: Effects of Avocado Consumption on Inflammation and Insulin Sensitivity in Adults With Elevated High Sensitivity-C-reactive Protein (Hs-CRP): A Randomized, Controlled Crossover Trial

Run by Midwest Center for Metabolic and Cardiovascular Research · NCT07566325 · Data updated 2026-11-12

This study tests whether swapping foods high in refined carbs with avocado (while keeping calories the same) lowers inflammation and improves insulin sensitivity in adults with elevated hs-CRP and central obesity.

More Overweight (BMI > 25) trials

Quick facts

Study typeInterventional
Ages21 Years to 74 Years
SexAll
Enrollment38 (estimated)
SponsorMidwest Center for Metabolic and Cardiovascular Research
Academic / other
Locations2 sites (Chicago, Illinois and 1 other locations)
StatusRecruiting
StartedJuly 2, 2026
Main results expectedFebruary 2027
Study endsFebruary 2027
Registry record updatedAugust 27, 2026
Trial IDNCT07566325 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 21–74 with BMI 25–39.9, central adiposity, and hs-CRP between 2 and 9.9 mg/L who are willing to consume study foods and maintain activity.

Probably not a fit

Participants who do not experience reductions in hs-CRP or improvements in insulin sensitivity may not benefit.

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

What this trial studies

Participants will try two 4-week eating patterns in random order: one includes about one avocado per day, and a control diet with similar calories but without avocado, separated by a 2-week washout. Each participant completes seven clinic visits for screening, baseline measurements, diet-period assessments, and a finish visit. The study focuses on adults with overweight or obesity, elevated hs-CRP, and central adiposity to see how isocaloric avocado substitution impacts inflammatory biomarkers and insulin sensitivity. The trial is led by the Midwest Center for Metabolic and Cardiovascular Research with Hass Avocado Board involvement, and will be conducted at Illinois Institute of Technology and University of Nevada, Las Vegas.

Why it matters

Potential benefit: If successful, the intervention could offer a simple dietary approach to lower inflammation in adults with central obesity.

How similar studies have gone: Similar dietary substitutions with healthy fats have shown potential inflammation-related benefits in some studies, but direct avocado substitution with isocaloric control is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Male or female 21 - 74 years of age, inclusive;
2. Baseline hs-CRP ≥2 to \<10 mg/L;
3. Central adiposity (waist circumference ≥35 inches in women and ≥40 inches in men);
4. Body mass index 25.0 to 39.9 kg/m2;
5. Normally active and judged by the Investigator to be in generally good health, based on medical history and screening measurements;
6. Willing to consume daily study foods during each diet condition;
7. Willing to maintain his/her regular physical activity pattern throughout the study period;
8. Willing to follow test day instructions (refrain from consumption of alcoholic beverages and participation in vigorous physical activity for 24 hours and tobacco and caffeine for 1 hour prior to each test visit);
9. No plans to change smoking, vaping, or other nicotine use habits during the study period; and
10. Premenopausal women that are not using hormonal contraceptives must have a history of regular menstrual cycles (21-35 days per cycle) for at least 3 months prior to visit 1;
11. Understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.

Exclusion Criteria:

1. Calculated energy needs of \<1800 kcal/d per the Mifflin-St. Jeor Equation, with an adjustment for energy expended in physical activity;
2. Known metabolic disease (e.g., type 1 or type 2 diabetes, metabolic dysfunction-associated steatohepatitis, etc.);
3. Laboratory test result(s) of clinical significance based on the judgment of the Principal Investigator or qualified designee, including fasting glucose ≥126 mg/dL;
4. Positive urine test for illicit drugs at visit 1;
5. Clinical atherosclerotic disease;
6. History or presence of clinically significant gastrointestinal, endocrine, renal, hepatic, hematologic, immunologic, dermatologic, pulmonary, pancreatic, neurologic, psychiatric, inflammatory or biliary disorder that, in the opinion of the Investigator, could interfere with the interpretation of the study results;
7. History of cancer in the prior 2 years, except for non- melanoma skin cancer or carcinoma in situ of the cervix;
8. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening;
9. Unstable use (defined as initiation or change in dose) of anti-hypertensive medication within 4 weeks of visit 1;
10. Unstable use (defined as initiation or change in dose) of thyroid hormone replacement medication within 12 weeks of visit 1;
11. Use of beta-adrenergic blockers and/or high-dose (\>25 mg/d) thiazide diuretics within 4 weeks of visit 1;
12. Use of diabetes medications including glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, alpha-glucosidase inhibitors, biguanides and biguanide combinations, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides and sulfonylureas and combination sulfonylureas within 4 weeks of visit 1;
13. Unstable use (defined as initiation or change in dose, agent, or regimen) of statins within 4 weeks of visit 1;
14. Use of lipid-altering drugs other than statins including, but not limited to bile acid sequestrants, cholesterol absorption inhibitors, or fibrates within 4 weeks of visit 1;
15. Use of any prescription medication with known effects on inflammation (e.g., colchicine, systemic corticosteroids) within 4 weeks of visit 1;
16. Frequent use (≥4 doses/week) of non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of visit 2;
17. Use of weight-loss drugs (including over-the-counter medications and/or supplements) or participation in a structured weight loss program within 4 weeks prior to visit 1;
18. Unstable use (initiation or change in dose) within 4 weeks of visit 1 of sex hormones. Multiphasic hormonal contraceptives in which the amount of sex hormone in the active pill varies by week (i.e., biphasic, triphasic, quadriphasic) are considered unstable doses of sex hormones and are exclusionary;
19. History of bariatric surgery or plans to have any surgery during the study;
20. History of any major trauma or major surgical event within 2 months of visit 1;
21. Use of herbs or dietary supplements that may affect lipid metabolism, including but not limited to omega-3 fatty acid supplements with \>500 mg of eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA), niacin (or its analogs) at doses \>200 mg/d, sterol/stanol products, dietary fiber supplements, red rice yeast supplements, garlic supplements, and soy isoflavone supplements within 2 weeks of visit 2;
22. Use of herbs and dietary supplements that may affect carbohydrate metabolism, including chromium picolinate, ginseng, cinnamon (as a supplement) and starch blockers within 2 weeks of visit 2;
23. Recent weight change of ±4.5 kg (\~10 lbs.) within 3 months prior to visit 1;
24. Has signs and symptoms of an active infection of clinical significance or has taken antibiotics within 5 days prior to any visit (washout is permitted by re-scheduling of the clinic visit);
25. Extreme dietary habits (e.g., vegan, very low carbohydrate);
26. History of an eating disorder (e.g., anorexia, bulimia nervosa, or binge eating) either diagnosed by a health professional or self-reported;
27. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period;
28. Known allergy, sensitivity, or intolerance to any components of the study foods;
29. Exposed to any non-registered drug product within 4 weeks of visit 1;
30. Currently participating in another research study;
31. Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-day washout prior to visit 2 and the participant must be willing to refrain from use during the study;
32. Current or recent history (past 12 months of screening) or strong potential for illicit drug or alcohol abuse. Alcohol abuse will be defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor); and
33. Condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Where it's running

  • Illinois Institute of Technology
    Chicago, Illinois, United States
    Recruiting
  • University of Nevada, Las Vegas
    Las Vegas, Nevada, United States
    Not yet recruiting

Study contacts

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.