Clinical Investigation on the Safety of Avocado Pulp Lipids
Obesity, Avocado, Overnutrition
About this trial
This is an interventional treatment trial for Obesity focused on measuring Avocado, Polyhydroxylated Fatty Alcohols, Avocatin B
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.
Sites / Locations
- Fundamentals of Health Naturopathic Medicine Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo
Low Dose
High Dose
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.