ClinicalTrials.gg
RecruitingNCT07566325Updated Aug 27, 2026

Assess the Effects of Replacing Foods High in Refined Carbohydrates With Avocado on Biomarkers of Inflammation.

An interventional study of Avocado and Control in Overweight (BMI > 25), Obesity (BMI>30) and Hs-CRP, sponsored by Midwest Center for Metabolic and Cardiovascular Research. Recruiting at 2 sites in United States. Open to participants aged 21 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Midwest Center for Metabolic and Cardiovascular Research · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
21 Years to 74 Years
Sex
All
01

Study summary

The objective of this trial is to assess the effects of replacing foods high in refined carbohydrates, particularly added sugars, with avocado (isocaloric substitution) on biomarkers of inflammation and insulin sensitivity in adults with elevated hs-CRP and central adiposity. Eligible participants will complete two 4-week interventions (1 avocado/d and control) separated by a 2-week washout phase. Participants will complete a total of 7 clinic visits including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 4-week diet condition (visit 3 \& 6 on day 21 and visits 4 \& 7 on day 28), and one visit at the conclusion of the washout phase/start of the second condition (visit 5, day 0).

02

Conditions studied

  • Overweight (BMI > 25)
  • Obesity (BMI>30)
  • Hs-CRP

Browse trials for

03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 38 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Midwest Center for Metabolic and Cardiovascular Research is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
21 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. 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 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 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

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 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 ) 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 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 ( 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 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 or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Avocado Group

    1 avocado/day provided by 3 servings study products per day (muffins and pudding)

    Other: Avocado

  • Other
    Control Group

    3 study products per day will be provided with energy from avocado will be replaced with refined carbohydrate, especially added sugars

    Other: Control

Interventions

  • OtherAvocado

    Active foods will provide the equivalent of one medium to large avocado/day in foods such as muffins and pudding, where avocado replaces refined carbohydrate, especially added sugars

  • OtherControl

    Control foods will have similar energy contents to active foods, but energy from avocado will be replaced with refined carbohydrate, especially added sugars.

06

What researchers measure

Primary outcomes

  1. Composite measure of inflammatory biomarkers

    Change from baseline for a composite measure of inflammatory biomarkers including high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), interleukin-10 (IL-10), and tumor Necrosis Factor-alpha (TNF-α).

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

Secondary outcomes

  1. Homeostasis model assessments of insulin resistance (HOMA-IR)

    Changes in (HOMA-IR)

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  2. Homeostasis model assessments of β-cell function (HOMA-B)

    Changes in HOMA-B

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  3. Matsuda index of insulin sensitivity

    Change in Matsuda index of insulin sensitivity

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  4. Disposition index

    Change in disposition index

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  5. high sensitivity C-reactive protein (hs-CRP)

    Change in hs-CRP

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  6. Interleukin-6 (IL-6)

    Change in IL-6

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  7. Interleukin-1 beta (IL-1β)

    Change in IL-1β

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  8. Interleukin-10 (IL-10)

    Change in IL-10

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  9. Tumor Necrosis Factor-alpha (TNF-α)

    Change in TNF-α

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  10. Fibrinogen

    Change in fibrinogen

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  11. Soluble Intercellular Adhesion Molecule-1 (sICAM-1)

    Change in sICAM-1

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  12. Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)

    Change in sVCAM-1

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  13. Total Cholesterol

    Change in total cholesterol

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  14. Low-density lipoprotein cholesterol (LDL-C)

    Change in LDL-C

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  15. High-density lipoprotein cholesterol (HDL-C)

    Change in HDL-C

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  16. Non-high-density lipoprotein cholesterol (non-HDL-C)

    Change in non-HDL-C

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  17. Triglycerides

    Change in triglycerides

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  18. Apolipoprotein B (ApoB)

    Change in ApoB

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

  19. Systolic and diastolic blood pressures.

    Change in resting, seated systolic and diastolic blood pressures.

    Time frame: Change from baseline (day 0) to end of each condition (day 28)

07

Study locations

1 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Feb 2027, 7 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 7 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2026
First posted
May 5, 2026
StartActual
Jul 2, 2026
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07566325
Lead sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
Hass Avocado Board
Responsible party
Sponsor
First posted
May 5, 2026
Start date
Jul 2, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Sara Campbell
Contact
scampbell@mbclinicalresearch.com
630-469-6600

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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