ObesityEarly Phase 1NCT03898505
Clinical Investigation on the Safety of Avocado Pulp Lipids
A Early Phase 1 study testing AvoMax (Low Dose) and AvoMax (High Dose) in people with Obesity and Avocado, run by University of Guelph at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Avocado, Overnutrition
- What is being tested?
- AvoMax (Low Dose) and AvoMax (High Dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2017to 1 Aug 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Fundamentals of Health Naturopathic Medicine Clinic
Waterloo, Ontario, N2L 6H6
About this study
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.
Read the 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.
- Conditions
- Obesity, Avocado, Overnutrition, Nutritional Disorder, Metabolic Disease, Lipid Metabolism Disorders
- Being tested
- AvoMax (Low Dose), AvoMax (High Dose), Placebo
- Keywords
- Avocado, Polyhydroxylated Fatty Alcohols, Avocatin B
- Medical subject headings
- Obesity, Overnutrition, Nutrition Disorders, Metabolic Diseases, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: AvoMax (High Dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events (AE)
Number of treatment emergent adverse events according to CTCAE v5.0.
Measured: During treatment period (Day 1 to Day 60)
Secondary outcomes (5)
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.
Measured: At screening and during treatment period (day 30 and day 60)
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.
Measured: At screening and during treatment period (day 30 and day 60)
Glycated Hemoglobin (HbA1c)
Mean absolute glycated hemoglobin (HbA1c) change from baseline
Measured: At screening and during treatment period (day 30 and day 60)
Body Weight
Mean absolute body weight change from baseline
Measured: At screening and during treatment period (day 30 and day 60)
Body Mass Index (BMI)
Mean absolute body mass index (BMI) change from baseline
Measured: At screening and during treatment period (day 30 and day 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start24 Nov 2017
- Primary completion25 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Orthomolecular Research
- Responsible party
- Principal investigator, Paul A. Spagnuolo, University of Guelph
- Investigators
- Paul Spagnuolo, PhD, Principal investigator, University of GuelphMary M Warndl, MD, Study chair, Medical MonitorKim Bretz, ND, Study director, Fundamentals of Health Naturopathic Medicine ClinicNawaz Ahmed, MSc, Study director, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898505
- Sponsor's protocol ID
- 232024
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation on the Safety of Avocado Pulp Lipids
- ClinicalTrials.gov ID
- NCT03898505
- Acronym / sponsor ID
- 232024
- Conditions
- Obesity, Avocado, Overnutrition, Nutritional Disorder, Metabolic Disease, Lipid Metabolism Disorders
- Keywords
- Avocado, Polyhydroxylated Fatty Alcohols, Avocatin B
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Advanced Orthomolecular Research
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo 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. |
| Low Dose | Experimental | Dietary Supplement: AvoMax (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. |
| High Dose | Experimental | Dietary Supplement: AvoMax (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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvoMax (Low Dose)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. | Dietary supplement | Low Dose |
| AvoMax (High Dose)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. | Dietary supplement | High Dose |
| PlaceboPlacebo 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. | Other | Placebo |
Primary outcome
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.
5 secondary outcomes
Hematology
Time frame: At screening and during treatment period (day 30 and day 60)
Biochemistry
Time frame: At screening and during treatment period (day 30 and day 60)
Glycated Hemoglobin (HbA1c)
Time frame: 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)
Body Mass Index (BMI)
Time frame: At screening and during treatment period (day 30 and day 60)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Spagnuolo, PhD principal investigator
University of Guelph
Mary M Warndl, MD study chair
Medical Monitor
Kim Bretz, ND study director
Fundamentals of Health Naturopathic Medicine Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AvoMax (Low Dose) and AvoMax (High Dose) in people with Obesity and Avocado, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AE) (time frame: During treatment period (Day 1 to Day 60)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.