Clinical Investigation on the Safety of Avocado Pulp Lipids

NCT03898505 | Completed Early Phase 1

• 1 other identifier: 232024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Avocado; Overnutrition; Nutritional Disorder; Metabolic Disease; Lipid Metabolism Disorders

Keywords

Avocado; Polyhydroxylated Fatty Alcohols; Avocatin B

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Adverse Events (AE)

  Number of treatment emergent adverse events according to CTCAE v5.0.

  During treatment period (Day 1 to Day 60)

Secondary Outcomes (5)

• Hematology

  At screening and during treatment period (day 30 and day 60)

• Biochemistry

  At screening and during treatment period (day 30 and day 60)

• Glycated Hemoglobin (HbA1c)

  At screening and during treatment period (day 30 and day 60)

• Body Weight

  At screening and during treatment period (day 30 and day 60)

• Body Mass Index (BMI)

  At screening and during treatment period (day 30 and day 60)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo 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. Participants in the placebo group will ingest 1 scoop of the placebo material per day (30-35g). Placebo powder is to be dissolved/blended in 12-16 ounces of a smoothie like diluent (e.g., 2% milk (with or without lactose), soy milk, coconut milk, or fruit juice of the participant's choice) and consumed orally. Placebo will be consumed once per day for 60 days.

Other: Placebo

Low Dose

EXPERIMENTAL

All Participants randomized to the low dose group will be consuming food grade avocado pulp powder (AvoMax) that will deliver a 50 mg dose of bioactive polyhydroxylated fatty alcohols (PFAs), avocadyne and avocadene. Participants in the low dose group will ingest 1 scoop of this test product per day (30-35g). Low dose test product is to be dissolved/blended in 12-16 ounces of a smoothie like diluent (e.g., 2% milk (with or without lactose), soy milk, coconut milk, or fruit juice of the participant's choice) and consumed orally. Low dose test product will be consumed once per day for 60 days.

Dietary Supplement: AvoMax (Low Dose)

High Dose

EXPERIMENTAL

All Participants randomized to the high dose group will be consuming food grade avocado pulp powder (AvoMax) that will deliver a 200 mg dose of bioactive polyhydroxylated fatty alcohols (PFAs), avocadyne and avocadene. Participants in the high dose group will ingest 1 scoop of this test product per day (30-35g). High dose test product is to be dissolved/blended in 12-16 ounces of a smoothie like diluent (e.g., 2% milk (with or without lactose), soy milk, coconut milk, or fruit juice of the participant's choice) and consumed orally. High dose test product will be consumed once per day for 60 days.

Dietary Supplement: AvoMax (High Dose)

Interventions

AvoMax (Low Dose) DIETARY_SUPPLEMENT

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.

Low Dose

AvoMax (High Dose) DIETARY_SUPPLEMENT

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.

High Dose

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guelph: lead
• Advanced Orthomolecular Research: collaborator

Study Sites (1)

Fundamentals of Health Naturopathic Medicine Clinic

Waterloo, Ontario, N2L 6H6, Canada

Location

MeSH Terms

Conditions

Obesity; Overnutrition; Nutrition Disorders; Metabolic Diseases; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Overweight; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Spagnuolo, PhD

  University of Guelph

  PRINCIPAL INVESTIGATOR

• Mary M Warndl, MD

  Medical Monitor

  STUDY CHAIR

• Kim Bretz, ND

  Fundamentals of Health Naturopathic Medicine Clinic

  STUDY DIRECTOR

• Nawaz Ahmed, MSc

  University of Guelph

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: November 24, 2017
• Primary Completion: June 25, 2018
• Study Completion: August 1, 2018
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

CA (1)