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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Avocado extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants will consume 10 grams of corn meal daily for 12 weeks. | Dietary Supplement: Placebo<br>* Participants will consume 10 grams of corn meal daily for 12 weeks.<br>|
| Experimental: Avocado extract<br>Participants will consume 10 grams of freeze dried avocado daily for 12 weeks. | Dietary Supplement: Avocado extract<br>* Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.<br>|

What is the study measuring?
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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 | 
| Waist circumference | Change in waist circumference | 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 | 
| Oxidative stress | Change in blood isoprostane | 12 weeks | 
| Autophagy | Changes in blood mRNA levels of autophagy markers | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Avocado extract, Cardiometabolic health