Clinical trial NCT03898505: Clinical Investigation on the Safety of Avocado Pulp Lipids
Official title: Clinical Investigation on the Safety of Avocado Pulp Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Avocado
Overnutrition
Nutritional Disorder
Metabolic Disease
Lipid Metabolism Disorders
Keywords: Avocado
Polyhydroxylated Fatty Alcohols
Avocatin B
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Advanced Orthomolecular Research
First posted: 2019-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* adults 18 to 60 years of age
* includes non-pregnant, non-breastfeeding women on adequate birth control
* stable body weight (BMI: 18.5-29.9)
* written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Pregnant or breastfeeding
* History or presence of diabetes
* History or presence of hypertension
* History or presence of dyslipidemia
* History or presence of major depressive disorders
* History or presence of chronic liver disorders
* History or presence of kidney disorders
* History or presence of blood disorders
* Previous bariatric surgery (or any major surgeries or medical procedures to be scheduled within the time frame of the study)
* Use of medication that causes significant weight gain or loss
* Allergies to or inhibitions consuming all three choices of: 2% lactose free milk, soy milk, or coconut milk
* Allergies to any ingredients in the placebo/investigational product
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Primary outcomes:
measure: Incidence and severity of Adverse Events (AE)
timeFrame: During treatment period (Day 1 to Day 60)
Secondary outcomes:
measure: Hematology
timeFrame: At screening and during treatment period (day 30 and day 60)
measure: Biochemistry
timeFrame: At screening and during treatment period (day 30 and day 60)
measure: Glycated Hemoglobin (HbA1c)
timeFrame: At screening and during treatment period (day 30 and day 60)
measure: Body Weight
timeFrame: At screening and during treatment period (day 30 and day 60)
measure: Body Mass Index (BMI)
timeFrame: At screening and during treatment period (day 30 and day 60)
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Fundamentals of Health Naturopathic Medicine Clinic
state: Ontario
Study officials:
affiliation: University of Guelph
name: Paul Spagnuolo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Monitor
name: Mary M Warndl, MD
role: STUDY_CHAIR
affiliation: Fundamentals of Health Naturopathic Medicine Clinic
name: Kim Bretz, ND
role: STUDY_DIRECTOR
affiliation: University of Guelph
name: Nawaz Ahmed, MSc
role: STUDY_DIRECTOR
References: