- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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-
Ontario
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Waterloo, Ontario, Canada, N2L 6H6
- Fundamentals of Health Naturopathic Medicine Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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.
|
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.
|
Experimental: Low Dose
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.
|
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.
|
Experimental: High Dose
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and severity of Adverse Events (AE)
Time Frame: During treatment period (Day 1 to Day 60)
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Number of treatment emergent adverse events according to CTCAE v5.0.
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During treatment period (Day 1 to Day 60)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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At screening and during treatment period (day 30 and day 60)
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Biochemistry
Time Frame: At screening and during treatment period (day 30 and day 60)
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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.
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At screening and during treatment period (day 30 and day 60)
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Glycated Hemoglobin (HbA1c)
Time Frame: At screening and during treatment period (day 30 and day 60)
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Mean absolute glycated hemoglobin (HbA1c) change from baseline
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At screening and during treatment period (day 30 and day 60)
|
Body Weight
Time Frame: At screening and during treatment period (day 30 and day 60)
|
Mean absolute body weight change from baseline
|
At screening and during treatment period (day 30 and day 60)
|
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
|
At screening and during treatment period (day 30 and day 60)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Spagnuolo, PhD, University of Guelph
- Study Chair: Mary M Warndl, MD, Medical Monitor
- Study Director: Kim Bretz, ND, Fundamentals of Health Naturopathic Medicine Clinic
- Study Director: Nawaz Ahmed, MSc, University of Guelph
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 232024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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