AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
- Conditions
- Obesity
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Avocado extract
- Registration Number
- NCT04763473
- Lead Sponsor
- University of Adelaide
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will consume 10 grams of corn meal daily for 12 weeks. Avocado extract Avocado extract Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Glycemic response 12 weeks Change in glucose area under the curve (AUC) in response to 75 g oral glucose tolerance test
- Secondary Outcome Measures
Name Time Method Blood lipids 12 weeks Change in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides
Postprandial insulin 12 weeks Change in insulin AUC in response to 75g oral glucose tolerance test
Waist circumference 12 weeks Change in waist circumference
Oxidative stress 12 weeks Change in blood isoprostane
Homeostatic model assessment of insulin resistance (HOMA-IR) 12 weeks Change in HOMA-IR
C-reactive protein 12 weeks Change in blood C-reactive protein
Fasting insulin 12 weeks Change in fasting insulin
Body weight 12 weeks Change in body weight
Body composition 12 weeks Change in body composition assessed by dual-energy X-ray absorptiometry (DEXA)
Blood pressure 12 weeks Change in systolic and diastolic blood pressure
Autophagy 12 weeks Changes in blood mRNA levels of autophagy markers
Fasting glucose 12 weeks Change in fasting glucose
Trial Locations
- Locations (1)
The University of Adelaide
🇦🇺Adelaide, South Australia, Australia