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Completed

NCT Number: NCT04763473

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Adelaide

Adelaide, South Australia, 5000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avocado extract

Dietary Supplement

Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.

Placebo

Dietary Supplement

Participants will consume 10 grams of corn meal daily for 12 weeks.

Primary outcomes

  1. Glycemic response

    Time frame: 12 weeks

    Change in glucose area under the curve (AUC) in response to 75 g oral glucose tolerance test

Secondary outcomes

  1. Fasting glucose

    Time frame: 12 weeks

    Change in fasting glucose

  2. Fasting insulin

    Time frame: 12 weeks

    Change in fasting insulin

  3. Postprandial insulin

    Time frame: 12 weeks

    Change in insulin AUC in response to 75g oral glucose tolerance test

  4. Homeostatic model assessment of insulin resistance (HOMA-IR)

    Time frame: 12 weeks

    Change in HOMA-IR

  5. Body weight

    Time frame: 12 weeks

    Change in body weight

  6. Waist circumference

    Time frame: 12 weeks

    Change in waist circumference

  7. Body composition

    Time frame: 12 weeks

    Change in body composition assessed by dual-energy X-ray absorptiometry (DEXA)

  8. Blood pressure

    Time frame: 12 weeks

    Change in systolic and diastolic blood pressure

  9. Blood lipids

    Time frame: 12 weeks

    Change in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides

  10. C-reactive protein

    Time frame: 12 weeks

    Change in blood C-reactive protein

  11. Oxidative stress

    Time frame: 12 weeks

    Change in blood isoprostane

  12. Autophagy

    Time frame: 12 weeks

    Changes in blood mRNA levels of autophagy markers

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Collaborators

  • Commonwealth Scientific and Industrial Research Organisation, Australia
  • Isagenix International LLC
  • Prolongevity Technologies

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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