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
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;
• 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.