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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763473
• Other study ID #: H-2020-248
• Status: Completed
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: August 11, 2022

Study information

• Verified date: April 2023
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Avocado extract
Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.
• Placebo
Participants will consume 10 grams of corn meal daily for 12 weeks.

Locations

Country	Name	City	State
Australia	The University of Adelaide	Adelaide	South Australia

Sponsors (4)

Lead Sponsor	Collaborator
University of Adelaide	Commonwealth Scientific and Industrial Research Organisation, Australia, Isagenix International LLC, Prolongevity Technologies

Country where clinical trial is conducted

Australia, 

Outcome

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