Ignite Creation Date:
2024-05-06 @ 12:58 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03898505
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2019-03-29
Brief Title:
Clinical Investigation on the Safety of Avocado Pulp Lipids
Sponsor:
University of Guelph
Organization:
University of Guelph
Study Overview
Official Title:
Clinical Investigation on the Safety of Avocado Pulp Lipids
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None