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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Avocado extract

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • The University of Adelaide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will consume 10 grams of corn meal daily for 12 weeks.	Dietary supplement: Placebo; Participants will consume 10 grams of corn meal daily for 12 weeks.
Experimental: Avocado extract; Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.	Dietary supplement: Avocado extract; Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic response	Change in glucose area under the curve (AUC) in response to 75 g oral glucose tolerance test	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	Change in fasting glucose	12 weeks
Fasting insulin	Change in fasting insulin	12 weeks
Postprandial insulin	Change in insulin AUC in response to 75g oral glucose tolerance test	12 weeks
Homeostatic model assessment of insulin resistance (HOMA-IR)	Change in HOMA-IR	12 weeks
Body weight	Change in body weight	12 weeks
Body composition	Change in body composition assessed by dual-energy X-ray absorptiometry (DEXA)	12 weeks
Blood pressure	Change in systolic and diastolic blood pressure	12 weeks
Blood lipids	Change in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides	12 weeks
C-reactive protein	Change in blood C-reactive protein	12 weeks
Waist circumference	Change in waist circumference	12 weeks
Oxidative stress	Change in blood isoprostane	12 weeks
Autophagy	Changes in blood mRNA levels of autophagy markers	12 weeks

Collaborators and Investigators

• Sponsor: University of Adelaide
• Collaborators: Commonwealth Scientific and Industrial Research Organisation, Australia; Isagenix International LLC; Prolongevity Technologies

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Cardiometabolic health; Avocado extract
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: H-2020-248

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No