Clinical trial NCT06081140: Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults
Official title: Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Keywords: whole food
botanical
dietary supplement
bioactive components
antioxidants
hemp oil complex
ECS
Nutrition
Lead sponsor: Standard Process Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Tolerance and palatability of short-term supplementation with a whole-food dietary formulation based on hemp oil, calamari oil, and broccoli was evaluated in healthy adults. This was a 10-day open-label, prospective, controlled trial (n=14) in which participants acted as their own controls to receive daily intervention standardized to contain 15 mg phytocannabinoids, 230 mg omega-3 fatty acids, and 5 mg glucoraphanin. The primary objective was to evaluate gastrointestinal tolerability and acceptability. The study demonstrated that daily ingestion of the investigational product was well tolerated with no or minor adverse events, and a good palatability. The secondary objectives were to access parameters of blood biochemistry, liver enzymes, biomarkers of immune and oxi-dative health, as well as phytocannabinoid profiles in urine.


Eligibility criteria: Inclusion Criteria:

* Subject is between 18 and 75 years old
* Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit, and is not actively planning a pregnancy
* If on a chronic medication (that does not result in exclusion), subject has been on stable dose for at least two months prior to screening visit
* Subject has at least two week wash out period between completion of a previous research study that required ingestion of any study food or drug, and their start in the current study
* No allergy to any study products
* Willingness to comply with study protocol for 10 days

Exclusion Criteria:

* Subjects who are experiencing any adverse events due to any nutraceutical, OTC, pharmaceutical, or investigational products
* Subjects may not receive any other investigational products not part of normal clinical care
* Lipid lowering drugs or the use of anticoagulant medications in the preceding 4 weeks and for duration of trial
* Subjects with untreated endocrine, neurological, or infectious disease
* Subjects with a current diagnosis or personal history of: significant liver or kidney disease, autoimmune disorders, deep vein thrombosis, history of cancer
* Serious medical illness including a history of attempted suicide
* Use of ethanol within 24 hours of the evaluation visits (baseline, and end of the study visit
* Do not comply with the study protocol

Primary outcomes:
measure: Tolerance
timeFrame: 10 days
measure: palatability
timeFrame: 10 days
Secondary outcomes:
measure: Oxidative Stress Biomarkers
timeFrame: 1 month
measure: Liver Enzymes
timeFrame: 1 month
measure: Medical Symptom Questionnaire (MSQ)
timeFrame: 10 days
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Standard Process Nutrition Innovation Center
state: North Carolina
Study officials:
References: