Clinical trial NCT04763473: AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
Official title: AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Avocado extract
Cardiometabolic health
Lead sponsor: University of Adelaide
Sponsor class: OTHER
Collaborators: name: Isagenix International LLC
name: Commonwealth Scientific and Industrial Research Organisation, Australia
name: Prolongevity Technologies
First posted: 2021-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Glycemic response
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting glucose
timeFrame: 12 weeks
measure: Fasting insulin
timeFrame: 12 weeks
measure: Postprandial insulin
timeFrame: 12 weeks
measure: Homeostatic model assessment of insulin resistance (HOMA-IR)
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Blood lipids
timeFrame: 12 weeks
measure: C-reactive protein
timeFrame: 12 weeks
measure: Oxidative stress
timeFrame: 12 weeks
measure: Autophagy
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: The University of Adelaide
state: South Australia
Study officials:
affiliation: The University of Adelaide
name: Leonie Heilbronn
role: PRINCIPAL_INVESTIGATOR
References: