Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults

Completed · Not applicable

Conditions studied: Diet, Healthy

In brief

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.

Key facts

Study ID

NCT06081140

Run by

Standard Process Inc.

People needed

14

Starts

2019-04-26

Expected to finish

2019-05-26

Last updated by the study team

2023-10-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Standard Process Nutrition Innovation Center — Kannapolis, North Carolina, United States

Full record on ClinicalTrials.gov

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