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Completed

NCT Number: NCT03898505

Clinical Investigation on the Safety of Avocado Pulp Lipids

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.

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Key information

Conditions

Obesity Avocado Body Weight Lipid Metabolism Disorders Metabolic Disease Metabolic Diseases Nutrition Disorders Nutritional Disorder Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Fundamentals of Health Naturopathic Medicine Clinic

Waterloo, Ontario, N2L 6H6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Incidence and severity of Adverse Events (AE)

    Time frame: During treatment period (Day 1 to Day 60)

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

Secondary outcomes

  1. Hematology

    Time frame: At screening and during treatment period (day 30 and day 60)

    Number of clinically relevant changes in hematology markers as assessed by: hematocrit (HCT), hemoglobin (Hb), red blood cell count (RBC), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cell count (WBC), differential blood count (neutrophils, lymphocytes, monocytes, eosinophils and basophils), reticulocytes absolute count, and mean platelet volume (MPV). Assessments will be performed at screening and during treatment period.

  2. Biochemistry

    Time frame: At screening and during treatment period (day 30 and day 60)

    Number of clinically relevant changes in serum biochemistry. Enzymes: alanine transaminase, creatine phosphokinase. Substrates: bilirubin (total), creatinine. Assessments will be performed at screening and during treatment period.

  3. Glycated Hemoglobin (HbA1c)

    Time frame: At screening and during treatment period (day 30 and day 60)

    Mean absolute glycated hemoglobin (HbA1c) change from baseline

  4. Body Weight

    Time frame: At screening and during treatment period (day 30 and day 60)

    Mean absolute body weight change from baseline

  5. Body Mass Index (BMI)

    Time frame: At screening and during treatment period (day 30 and day 60)

    Mean absolute body mass index (BMI) change from baseline

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Advanced Orthomolecular Research

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2019
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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