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

University of Adelaide

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: Avocado extract

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04763473

H-2020-248

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.