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).
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;
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;
Crossover
Avocado
Other interventionActive 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
Control
Other interventionControl foods will have similar energy contents to active foods, but energy from avocado will be replaced with refined carbohydrate, especially added sugars.
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).
Homeostasis model assessments of insulin resistance (HOMA-IR)
Changes in (HOMA-IR)
Homeostasis model assessments of β-cell function (HOMA-B)
Changes in HOMA-B
Matsuda index of insulin sensitivity
Change in Matsuda index of insulin sensitivity
Disposition index
Change in disposition index
Click on the lead sponsor to view all of their trials.
Midwest Center for Metabolic and Cardiovascular Research
Lead sponsor
Hass Avocado Board
Collaborator
