AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)

AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)

This two-arm, double blind, randomized clinical trial will compare the effect of an avocado extract, compared to placebo, on cardiometabolic outcomes in adults with obesity.

Sixty eligible participants will be stratified by sex and randomly assigned to placebo or avocado extract supplementation group for 12 weeks. Metabolic testing will be performed at baseline, and at the end of the intervention.

Inclusion Criteria:

• Men and women 25 - 65 years old
• Waist circumference (>94cm in men and >80cm in women)
• BMI 30 - 40 kg/m2
• Willingness to provide written informed consent and willingness to participate and comply with the study

Exclusion Criteria:

• Women planning pregnancy during the course of the study or 3 months after completion of the study, or who are lactating
• Individuals diagnosed with type 1 or type 2 diabetes mellitus, liver or kidney diseases, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac), cardiovascular event in the previous 6 months, or any other condition deemed unstable
• Biochemical abnormalities or evidence at screening of disease including elevated liver enzymes ALT and/or AST >3 times normal range limit
• Not weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry).
• Current or recent (within 12 months) treatment with medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins']), medications affecting weight, appetite or gut motility (i.e. domperidone, cisapride, orlistat, phentermine, topiramate). Participants who are taking stable doses (i.e. > 12 months) of androgenic medications (i.e. testosterone), thyroxine, corticosteroids, anti-depressants (selective serotonin reuptake inhibitors), anti-hypertensives (ace-inhibitors, calcium channel blockers, beta-blockers, diuretics) and lipid lowering medications (statins, fibrates) will not be excluded.
• Participants who have had bariatric surgery
• Participants with conditions that may interfere with the ability to understand the requirements of the study.