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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-74
SponsorMidwest Center for Metabolic and Cardiovascular Research

About this 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).

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Avocado
  • Control

Treatment groups

38 Participants
are divided into 2 treatment groups

Sponsors and collaborators