Assess the Effects of Replacing Foods High in Refined Carbohydrates With Avocado on Biomarkers of… (NCT07566325) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assess the Effects of Replacing Foods High in Refined Carbohydrates With Avocado on Biomarkers of Inflammation.
United States38 participantsStarted 2026-05-11
Plain-language 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).
Who can participate
Age range21 Years – 74 Years
SexALL
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Inclusion criteria
✓. 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);
Exclusion criteria
✕. Calculated energy needs of \<1800 kcal/d per the Mifflin-St. Jeor Equation, with an adjustment for energy expended in physical activity;
What they're measuring
1
Composite measure of inflammatory biomarkers
Timeframe: Change from baseline (day 0) to end of each condition (day 28)
Trial details
NCT IDNCT07566325
SponsorMidwest Center for Metabolic and Cardiovascular Research
✕. 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;