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

NCT07566325 | Not Yet Recruiting

• 1 other identifier: MB-2544
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this trial is to assess the effects of replacing foods high in refined carbohydrates, particularly added sugars, with avocado (isolacaloric 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).

Conditions

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

Outcome Measures

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).

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

Secondary Outcomes (19)

• Homeostasis model assessments of insulin resistance (HOMA-IR)

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

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

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

• Matsuda index of insulin sensitivity

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

• Disposition index

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

• high sensitivity C-reactive protein (hs-CRP)

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

Study Arms (2)

Avocado Group

EXPERIMENTAL

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

Other: Avocado

Control Group

OTHER

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

Other: Control

Interventions

Avocado OTHER

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

Avocado Group

Control OTHER

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

Control Group

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 21 - 74 years of age, inclusive;
• Baseline hs-CRP ≥2 to \<10 mg/L;
• Central adiposity (waist circumference ≥35 inches in women and ≥40 inches in men);
• Body mass index 25.0 to 39.9 kg/m2;
• Normally active and judged by the Investigator to be in generally good health, based on medical history and screening measurements;
• Willing to consume daily study foods during each diet condition;
• Willing to maintain his/her regular physical activity pattern throughout the study period;
• 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);
• No plans to change smoking, vaping, or other nicotine use habits during the study period; and
• 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;
• 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.

You may not qualify if:

• Calculated energy needs of \<1800 kcal/d per the Mifflin-St. Jeor Equation, with an adjustment for energy expended in physical activity;
• Known metabolic disease (e.g., type 1 or type 2 diabetes, metabolic dysfunction-associated steatohepatitis, etc.);
• Laboratory test result(s) of clinical significance based on the judgment of the Principal Investigator or qualified designee, including fasting glucose ≥126 mg/dL;
• Positive urine test for illicit drugs at visit 1;
• Clinical atherosclerotic disease;
• 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;
• History of cancer in the prior 2 years, except for non- melanoma skin cancer or carcinoma in situ of the cervix;
• Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening;
• Unstable use (defined as initiation or change in dose) of anti-hypertensive medication within 4 weeks of visit 1;
• Unstable use (defined as initiation or change in dose) of thyroid hormone replacement medication within 12 weeks of visit 1;
• Use of beta-adrenergic blockers and/or high-dose (\>25 mg/d) thiazide diuretics within 4 weeks of visit 1;
• 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;
• Unstable use (defined as initiation or change in dose, agent, or regimen) of statins within 4 weeks of visit 1;
• 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;
• Use of any prescription medication with known effects on inflammation (e.g., colchicine, systemic corticosteroids) within 4 weeks of visit 1;

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• Hass Avocado Board: collaborator

Study Sites (2)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sara Campbell

CONTACT

630-469-6600; scampbell@mbclinicalresearch.com

Caryn Adams

CONTACT

cwolfe@mbclinicalresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (2)