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Clinical Investigation on the Safety of Avocado Pulp Lipids

Primary Purpose

Obesity, Avocado, Overnutrition

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
AvoMax (Low Dose)
AvoMax (High Dose)
Placebo
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Avocado, Polyhydroxylated Fatty Alcohols, Avocatin B

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fundamentals of Health Naturopathic Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Low Dose

High Dose

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Incidence and severity of Adverse Events (AE)
Number of treatment emergent adverse events according to CTCAE v5.0.

Secondary Outcome Measures

Hematology
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.
Biochemistry
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.
Glycated Hemoglobin (HbA1c)
Mean absolute glycated hemoglobin (HbA1c) change from baseline
Body Weight
Mean absolute body weight change from baseline
Body Mass Index (BMI)
Mean absolute body mass index (BMI) change from baseline

Full Information

First Posted
March 29, 2019
Last Updated
April 1, 2019
Sponsor
University of Guelph
Collaborators
Advanced Orthomolecular Research
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1. Study Identification

Unique Protocol Identification Number
NCT03898505
Brief Title
Clinical Investigation on the Safety of Avocado Pulp Lipids
Official Title
Clinical Investigation on the Safety of Avocado Pulp Lipids
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 24, 2017 (Actual)
Primary Completion Date
June 25, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
Advanced Orthomolecular Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Avocado, Overnutrition, Nutritional Disorder, Metabolic Disease, Lipid Metabolism Disorders
Keywords
Avocado, Polyhydroxylated Fatty Alcohols, Avocatin B

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
High Dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
AvoMax (Low Dose)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
AvoMax (High Dose)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Incidence and severity of Adverse Events (AE)
Description
Number of treatment emergent adverse events according to CTCAE v5.0.
Time Frame
During treatment period (Day 1 to Day 60)
Secondary Outcome Measure Information:
Title
Hematology
Description
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.
Time Frame
At screening and during treatment period (day 30 and day 60)
Title
Biochemistry
Description
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.
Time Frame
At screening and during treatment period (day 30 and day 60)
Title
Glycated Hemoglobin (HbA1c)
Description
Mean absolute glycated hemoglobin (HbA1c) change from baseline
Time Frame
At screening and during treatment period (day 30 and day 60)
Title
Body Weight
Description
Mean absolute body weight change from baseline
Time Frame
At screening and during treatment period (day 30 and day 60)
Title
Body Mass Index (BMI)
Description
Mean absolute body mass index (BMI) change from baseline
Time Frame
At screening and during treatment period (day 30 and day 60)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Spagnuolo, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary M Warndl, MD
Organizational Affiliation
Medical Monitor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kim Bretz, ND
Organizational Affiliation
Fundamentals of Health Naturopathic Medicine Clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nawaz Ahmed, MSc
Organizational Affiliation
University of Guelph
Official's Role
Study Director
Facility Information:
Facility Name
Fundamentals of Health Naturopathic Medicine Clinic
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 6H6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Clinical Investigation on the Safety of Avocado Pulp Lipids

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