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

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ClinicalTrials.gov Identifier: NCT04763473
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Isagenix International LLC
Commonwealth Scientific and Industrial Research Organisation, Australia
Prolongevity Technologies
Information provided by (Responsible Party):
A/Prof Leonie Heilbronn, University of Adelaide

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Avocado extract Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
Actual Study Start Date : March 9, 2021
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 15, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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. Hemoglobin A1c (HbA1c) [ Time Frame: 12 weeks ]
    Change in HbA1c

  6. Body weight [ Time Frame: 12 weeks ]
    Change in body weight

  7. Waist and hip circumference [ Time Frame: 12 weeks ]
    Change in waist hip circumference

  8. Body composition [ Time Frame: 12 weeks ]
    Change in body composition assessed by dual-energy X-ray absorptiometry (DEXA)

  9. Blood pressure [ Time Frame: 12 weeks ]
    Change in systolic and diastolic blood pressure

  10. Blood lipids [ Time Frame: 12 weeks ]
    Change in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides

  11. C-reactive protein [ Time Frame: 12 weeks ]
    Change in blood C-reactive protein


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763473


Contacts
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Contact: Leonie Heilbronn +61881284838 leonie.heilbronn@adelaide.edu.au

Locations
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Australia, South Australia
The University of Adelaide Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Leonie Heilbronn, PhD    +61 08 81284838    leonie.heilbronn@adelaide.edu.au   
Sub-Investigator: Bo Liu, PhD         
Sponsors and Collaborators
University of Adelaide
Isagenix International LLC
Commonwealth Scientific and Industrial Research Organisation, Australia
Prolongevity Technologies
Investigators
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Principal Investigator: Leonie Heilbronn The University of Adelaide
More Information
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Responsible Party: A/Prof Leonie Heilbronn, Associate Professor, University of Adelaide
ClinicalTrials.gov Identifier: NCT04763473    
Other Study ID Numbers: H-2020-248
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by A/Prof Leonie Heilbronn, University of Adelaide:
Obesity
Avocado extract
Cardiometabolic health
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight