Clinical Investigation on the Safety of Avocado Pulp Lipids
Condition: Obesity; Avocado; Overnutrition; Nutritional Disorder; Metabolic Disease; Lipid Metabolism Disorders
MeSH terms: Metabolic Diseases; Lipid Metabolism Disorders; Overnutrition; Nutrition Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Obesity and diabetes are a significant global burden and there is an immediate need for novel
      treatments and management strategies. Our laboratory determined that avocado derived 17
      carbon polyhydroxylated fatty alcohols (PFAs) are inhibitors of fatty acid oxidation (FAO)
      that impart minimal toxicity in mice. FAO is altered in numerous disease states including
      obesity and diabetes. In these chronic diseases, excessive FAO in muscle and liver
      mitochondria cause metabolic overload and inefficiency which drives obesity-associated
      glucose intolerance and insulin insensitivity. The increased FAO that occurs in obese and
      diabetic individuals depletes several substrates and intermediates of the Krebs cycle, making
      them less efficient at using oxidative phosphorylation for energy, which can ultimately lead
      to glucose insensitivity and weight gain. For these reasons, inhibition of FAO is now an
      established therapeutic approach for the treatment of type II diabetes as reducing FAO: i)
      improves cellular metabolism to shift towards the more thermogenic oxidative phosphorylation
      and glycolysis, and ii) reduces hyperglycemia via inhibiting liver gluconeogenesis while
      improving glucose homeostasis.

      In collaboration with an industry partner, Advanced Orthomolecular Research (AOR; Calgary,
      AB), the investigators have developed a supplement containing a blend of 17-carbon PFAs found
      inside a commercially available food grade avocado powder. The primary objective of this
      clinical trial is to determine if the avocado derived supplement is safe for oral consumption
      compared to a placebo-controlled group.
    

Detailed description: 
      This is a single center, double-blind, placebo-controlled, randomized clinical trial. 30
      healthy subjects are planned. After screening and recruitment, subjects will be randomly
      allocated to treatment groups (low dose avocado powder or high dose avocado powder) or
      placebo control group. Once recruitment, randomization, baseline measurements as well as
      treatment allocation is completed (on the first site visit), each subject will orally consume
      one scoop (30-35g of material) of the avocado supplement, blended in 12-16 ounces of a
      smoothie like diluent, once per day for 60 days. The placebo group will also consume one
      scoop (30-35g of material) containing only non-medicinal ingredients used in the test
      product. Primary and secondary endpoint evaluations will be taken at baseline (site visit 2),
      day 30 (site visit 3) and day 60 (site visit 4) at each of the 3 study site visits as well as
      via weekly telephone calls to participants. Total duration of subject participation will be
      60 days. Total duration of the study is expected to be 61 days.
    

Intervention name(s): AvoMax (Low Dose); AvoMax (High Dose); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): AvoMax (Low Dose) is a natural spray-dried avocado powder, which contains 50 mg of a combination of bioactive polyhydroxylated fatty alcohols (PFAs), avocadyne and avocadene.; AvoMax (High Dose) is a natural spray-dried avocado powder, which contains a total of 200 mg of a combination of bioactive polyhydroxylated fatty alcohols (PFAs), avocadyne and avocadene.; Placebo product is powder containing only non-medicinal ingredients used in the test product: Oryza sativa (rice) bran extract (65-70% w/w of total placebo formulation), sodium bicarbonate, rosemary extract, xylitol, silicon dioxide, microcrystalline cellulose, rice hull powder, strawberry flavour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Avocado; Polyhydroxylated Fatty Alcohols; Avocatin B